Wire, Guide, Catheter
FDA product code DQX · Class II (moderate risk) · 21 CFR 870.1330 · Cardiovascular
767510(k) clearances
0PMA approvals
241recalls
Manufacturers
- Asahi Intecc Co., Ltd. 47
- Advanced Cardiovascular Systems, Inc. 45
- Boston Scientific Corporation 34
- Lake Region Mfg., Inc. 31
- Scimed Life Systems, Inc. 30
- Guidant Corp. 27
- Cook, Inc. 26
- Cordis Corp. 25
- Merit Medical Systems, Inc. 22
- Target Therapeutics 22
- Abbott Vascular 19
- Lake Region Medical 13
- C.R. Bard, Inc. 11
- Terumo Medical Corp. 11
- Vascular Solutions, Inc. 11
- Datascope Corp. 10
- Intra Luminal Therapeutics, Inc. 10
- Cardio Metrics, Inc. 9
- Brivant, Ltd. 9
- Neometrics, Inc. 9
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
| K251596 | Lunderquist Extra Stiff Wire GuideDQX · Special | William Cook Europe Aps | 11/09/2025SE |
| K250203 | SureAx-GuideDQX · Traditional | Sureax Medical, LLC | 10/17/2025SE |
| K250031 | Amplatzer GuidewireDQX · Traditional | Abbott Medical | 10/03/2025SE |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire…DQX · Special | Merit Medical Ireland, Ltd. | 08/29/2025SE |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQX · Traditional | Abbott Medical | 07/25/2025SE |
| K250075 | Medtronic Stedi Extra Support GuidewireDQX · Traditional | Medtronic, Inc. | 06/13/2025SE |
| K243733 | SION blue PLUSDQX · Special | Asahi Intecc Co., Ltd. | 04/02/2025SE |
| K241962 | CrossloopDQX · Traditional | Asahi Intecc Co., Ltd. | 03/27/2025SE |
| K242597 | CROSSLEAD 0.018inchDQX · Special | Asahi Intecc Co., Ltd. | 03/05/2025SE |
| K241702 | CROSSLEAD 0.014inchDQX · Special | Asahi Intecc Co., Ltd. | 02/06/2025SE |
| K241521 | Prelude Small O.D. Introducer Guide WireDQX · Traditional | Merit Medical Systems, Inc. | 12/10/2024SE |
| K242824 | PTFE GuidewireDQX · Special | Lake Region Medical | 12/06/2024SE |
| K240818 | R2P Radifocus Glidewire AdvantageDQX · Traditional | Terumo Corporation | 11/26/2024SE |
| K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireDQX · Traditional | Abbott Medical | 11/06/2024SE |
| K241784 | Arrow® Nitinol WireDQX · Traditional | Teleflex Medical | 09/18/2024SE |
| K240859 | Glidewire GT-RDQX · Traditional | Terumo Corporation | 08/21/2024SE |
| K241510 | CROSSLEAD TrackerDQX · Special | Asahi Intecc Co., Ltd. | 08/14/2024SE |
| K240387 | MINAMO blue; MINAMO violaDQX · Traditional | Asahi Intecc Co., Ltd. | 06/21/2024SE |
| K240460 | FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)DQX · Special | FMD Co., Ltd. | 06/13/2024SE |
| K240864 | PacePro WireDQX · Traditional | Opsens, Inc. | 05/24/2024SE |
| K232662 | BNLE Hydrophilic Jacketed Peripheral GuidewireDQX · Traditional | Biomerics Nle | 05/14/2024SE |
| K230418 | Mighty Wire Guide WireDQX · Traditional | Merit Medical Systems, Inc. | 10/28/2023SE |
| K232570 | Steerant Super Stiff GuidewireDQX · Traditional | Medtronic Vascular | 10/24/2023SE |
| K232578 | Vassallo GT 018 G12; Vassallo GT 018 G30DQX · Special | Filmec Co. , Ltd. | 10/11/2023SE |
| K232574 | VASSALLO GT Crossing14DQX · Special | Filmec Co. , Ltd. | 10/11/2023SE |
| K230377 | CROSSLEAD Penetration Peripheral Guide WireDQX · Special | Asahi Intecc Co., Ltd. | 07/20/2023SE |
| K223791 | TalWireDQX · Traditional | Embrace Medical , Ltd. | 07/14/2023SE |
| K230637 | Wattson temporary pacing guidewire (2250)DQX · Traditional | Vascular Solutions, LLC | 05/05/2023SE |
| K221390 | BNLE Access GuidewireDQX · Traditional | Biomerics Nle | 04/28/2023SE |
| K223432 | Vassallo GT 018 HybridDQX · Traditional | Filmecc Co., Ltd. | 03/09/2023SE |
| K213898 | ProTrack Pigtail WireDQX · Traditional | Baylis Medical Company, Inc. | 03/01/2023SE |
| K221351 | Mechanical GuidewireDQX · Traditional | Baylis Medical Company, Inc. | 12/19/2022SE |
| K222631 | Vassallo GT ExtDQX · Traditional | Filmecc Co., Ltd. | 10/26/2022SE |
| K221575 | Pre-Formed BlueDQX · Traditional | Lake Region Medical | 10/07/2022SE |
| K212615 | EpiFaith CVDQX · Traditional | Flat Medical Co., Ltd. | 09/21/2022SE |
| K213854 | SavvyWireDQX · Traditional | Opsens, Inc. | 09/14/2022SE |
| K213868 | ASAHI Gladius Mongo18 PV ESDQX · Traditional | Asahi Intecc Co., Ltd. | 09/06/2022SE |
| K221917 | Stent Positioning Assistance System (SPAS)DQX · Traditional | Seven Sons , Ltd. | 08/19/2022SE |
| K213315 | CROSSLEAD Peripheral Guide WireDQX · Traditional | Asahi Intecc Co., Ltd. | 07/01/2022SE |
| K213949 | VASSALLO GT 018 FloppyDQX · Traditional | Filmecc Co., Ltd. | 06/30/2022SE |
| K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTDQX · Traditional | FMD Co., Ltd. | 05/27/2022SE |
| K210548 | Medline Integrated Arterial CatheterDQX · Traditional | Centurion Medical Products | 05/17/2022SE |
| K220075 | Spartan Center WireDQX · Traditional | Spartan Micro, Inc. | 04/19/2022SE |
| K213834 | Cardio Flow Peripheral Guide WireDQX · Traditional | Cardio Flow Inc., | 03/18/2022SE |
| K220137 | Lunderquist Extra Stiff Wire GuideDQX · Special | William Cook Europe Aps | 02/17/2022SE |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireDQX · Traditional | Vascular Solutions, LLC | 02/09/2022SE |
| K211898 | ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20DQX · Special | Asahi Intecc Co., Ltd. | 12/08/2021SE |
| K211741 | Pre-Formed Extra Support GuidewireDQX · Traditional | Lake Region Medical | 11/22/2021SE |
| K203529 | VASSALLO GT HybridDQX · Traditional | Filmecc Co., Ltd. | 05/04/2021SE |
| K203533 | Vassallo GTDQX · Traditional | Filmecc Co., Ltd. | 04/21/2021SE |
| K210235 | Verrata PLUS Pressure Guide WireDQX · Special | Volcano Corporation | 04/15/2021SE |
| K201720 | LiPPS Analyzer, LiPPS Wire Pressure Guide WireDQX · Traditional | Beijing Bywave Sensing Medical Technology Co.… | 02/18/2021SE |
| K201595 | Merit Hydrophilic Guide WireDQX · Traditional | Merit Medical Systems, Inc. | 10/14/2020SE |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Special | Volcano Corporation | 09/28/2020SE |
| K193653 | Hydrophilic Coating Guide WireDQX · Traditional | Suzhou Hengrui Disheng Medical Co., Ltd. | 08/26/2020SE |
| K201834 | HI-TORQUE PROCEED Guide Wire FamilyDQX · Special | Abbott Vascular | 07/30/2020SE |
| K201760 | Zoom 14 GuidewireDQX · Special | Scientia Vascular, LLC | 07/29/2020SE |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireDQX · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 07/21/2020SE |
| K200120 | LiteSaber Wire Torque Assist DeviceDQX · Traditional | Vesatek, LLC | 05/07/2020SE |
| K200144 | HI-TORQUE Steelcore Bare Guide WireDQX · Traditional | Abbott Vascular | 04/08/2020SE |
| K193571 | Go2Wire Guide WireDQX · Traditional | Merit Medical System, Inc. | 04/08/2020SE |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Traditional | Volcano Corporation | 03/26/2020SE |
| K193548 | Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireDQX · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 01/18/2020SE |
| K192454 | Wattson Temporary Pacing GuidewireDQX · Traditional | Vascular Solutions | 01/15/2020SE |
| K192599 | ASAHI PTCA Guide Wire ASAHI Gaia NextDQX · Special | Asahi Intecc Co., Ltd. | 01/02/2020SE |
| K191907 | OptoWire IIIDQX · Traditional | Opsens, Inc. | 01/02/2020SE |
| K193194 | CrossTorq 14 GuidewireDQX · Traditional | Scientia Cardio Access, LLC | 12/13/2019SE |
| K193126 | HI-TORQUE InfilTrac Guide Wire FamilyDQX · Special | Abbott Vascular | 12/11/2019SE |
| K191502 | Heraeus Peripheral GuidewireDQX · Traditional | Heraeus Medical Components, LLC | 11/26/2019SE |
| K191464 | Asahi PTCA Guide Wire Asahi SION SeriesDQX · Traditional | Asahi Intecc Co., Ltd. | 11/21/2019SE |
| K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…DQX · Special | Scientia Vascular, LLC | 10/30/2019SE |
| K191687 | pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WireDQX · Traditional | Phenox Limited | 10/09/2019SE |
| K190176 | MinamoDQX · Traditional | Asahi Intecc Co., Ltd. | 08/01/2019SE |
| K182985 | Roadrunner PC Wire Guide, Olcott Torque DeviceDQX · Traditional | Cook Incorporated | 07/22/2019SE |
| K183062 | ASAHI SilverwayDQX · Traditional | Asahi Intecc Co., Ltd. | 07/01/2019SE |
| K182457 | Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor…DQX · Traditional | Brivant Limited (Lake Region Medical) | 04/18/2019SE |
| K182553 | Inno-PathwireDQX · Traditional | Suzhou Innomed Medical Device Co., Ltd. | 03/11/2019SE |
| K181353 | Lunderquist® Fixed Core Wire GuideDQX · Traditional | Cook Incorporated | 02/15/2019SE |
| K183467 | Roadrunner Extra Support Wire GuideDQX · Special | Cook Incorporated | 01/11/2019SE |
| K180830 | Reuter Tip Deflecting Wire GuideDQX · Traditional | Cook Incorporated | 12/20/2018SE |
| K182315 | Magic Torque DLVR GuidewireDQX · Special | Boston Scientific Corporation | 09/26/2018SE |
| K181647 | Bandit guidewireDQX · Special | Vascular Solutions, Inc. | 07/20/2018SE |
| K180784 | ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ESDQX · Traditional | Asahi Intecc Co., Ltd. | 07/18/2018SE |
| K173277 | ASAHI PTCA Guide Wire ASAHI SION blackDQX · Traditional | Asahi Intecc Co., Ltd. | 07/05/2018SE |
| K180726 | Savion DLVR Guidewire, Savion FLX GuidewireDQX · Traditional | Boston Scientific, Inc. | 06/18/2018SE |
| K181351 | Double Flexible Tipped Wire GuidesDQX · Special | Cook Incorporated | 06/14/2018SE |
| K181001 | Medtronic Confida Brecker GuidewireDQX · Traditional | Medtronic Core Valve, LLC | 05/03/2018SE |
| K180795 | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireDQX · Special | Boston Scientific | 04/12/2018SE |
| K172187 | Inno-HydrowireDQX · Traditional | Suzhou Innomed Medical Device Co., Ltd. | 04/11/2018SE |
| K171997 | Mandril Wire GuideDQX · Traditional | Cook Incorporated | 03/30/2018SE |
| K171912 | Double Flexible Tip Wire GuidesDQX · Traditional | Cook Incorporated | 03/19/2018SE |
| K171764 | Fixed Core Wire GuidesDQX · Traditional | Cook Incorporated | 03/09/2018SE |
| K180128 | Warrior 14 guidewireDQX · Traditional | Vascular Solutions, Inc. | 02/16/2018SE |
| K171933 | ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterDQX · Traditional | Asahi Intecc Co., Ltd. | 02/12/2018SE |
| K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support…DQX · Traditional | Scientia Vascular, LLC | 01/22/2018SE |
| K173795 | HI-TORQUE TurnTrac Guide Wire FamilyDQX · Special | Abbott Vascular | 01/12/2018SE |
| K171445 | Amplatz Support Wire Guide with Apex CurveDQX · Traditional | Cook Incorporated | 01/10/2018SE |
| K171948 | Roadrunner Extra Support Wire GuideDQX · Special | Cook Incorporated | 01/05/2018SE |
| K173532 | Raider GuidewireDQX · Traditional | Vascular Solutions, Inc. | 12/15/2017SE |
| K171513 | Lunderquist Extra Stiff Wire GuideDQX · Traditional | William Cook Europe Aps | 12/07/2017SE |
| K170915 | TXM Hydrophilic GuidewireDQX · Traditional | Texasmedical Technologies, Inc. | 11/21/2017SE |
| K173423 | MR Wire Guide Wire Straight, MR Wire Guide Wire AngledDQX · Special | Nano4imaging GmbH | 11/17/2017SE |
| K172453 | WATCHDOG Hemostasis Valve KitDQX · Traditional | Boston Scientific Corporation | 11/09/2017SE |
| K173052 | Heraeus TMW GuidewireDQX · Traditional | Heraeus Medical Components, LLC | 10/20/2017SE |
| K170417 | Glidewire GTDQX · Traditional | Terumo Corporation | 09/15/2017SE |
| K172073 | Hi-Torque Command 18 Guide WireDQX · Special | Abbott Vascular | 08/25/2017SE |
| K171897 | Approach CTO Microwire GuideDQX · Traditional | Cook Incorporated | 08/21/2017SE |
| K170532 | True Form Reshapable Guide WireDQX · Traditional | Merit Medical Systems, Inc. | 07/21/2017SE |
| K170684 | Firebow Wire Torque Assist DeviceDQX · Traditional | Vesatek, LLC | 06/29/2017SE |
| K170933 | Merit Hydrophilic Guide WireDQX · Special | Merit Medical Systems, Inc. | 06/22/2017SE |
| K170700 | Inqwire Diagnostic Guide WireDQX · Special | Merit Medical Systems, Inc. | 04/06/2017SE |
| K163426 | ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionDQX · Traditional | Asahi Intecc Co., Ltd. | 04/03/2017SE |
| K170636 | Fathom-16 Steerable GuidewiresDQX · Special | Boston Scientific Corporation | 03/22/2017SE |
| K163575 | Inqwire Diagnostic Guide WireDQX · Special | Merit Medical Systems, Inc. | 03/03/2017SE |
| K163004 | Radifocus Glidewire Advantage TrackDQX · Traditional | Ashitaka Factory of Terumo Coporation | 01/30/2017SE |
| K162842 | ASAHI PTCA Guide Wire ASAHI SUOH 03DQX · Traditional | Asahi Intecc Co., Ltd. | 01/27/2017SE |
| K163444 | Spectre guidewireDQX · Special | Vascular Solutions, Inc. | 01/06/2017SE |
| K160785 | Worker GuidewireDQX · Traditional | Argon Medical Devices, Inc. | 12/08/2016SE |
| K161702 | Endura guidewireDQX · Traditional | Vascular Solutions, Inc. | 12/06/2016SE |
| K160594 | MRWire Guide WireDQX · Traditional | Nano4imaging GmbH | 11/22/2016SE |
| K160643 | ENROUTE 0.014 GuidewireDQX · Traditional | Lake Region Medical | 10/18/2016SE |
| K153685 | Sunmed Haemostatic ValvesDQX · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 10/13/2016SE |
| K161584 | ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16DQX · Traditional | Asahi Intecc Co., Ltd. | 10/06/2016SE |
| K161887 | Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire…DQX · Special | Volcano Corporation | 09/20/2016SE |
| K153397 | S-Wire Guidewire SystemDQX · Traditional | Concert Medical, LLC | 08/18/2016SE |
| K153106 | ASAHI Fielder XT-A, ASAHI Fielder XT-RDQX · Traditional | Asahi Intecc Co., Ltd. | 06/21/2016SE |
| K160018 | Arrow Quickflash Arterial Catheterization DeviceDQX · Traditional | Arrow International, Inc. (Subsidiary of… | 06/13/2016SE |
| K153443 | ASAHI Astato XS 40DQX · Traditional | Asahi Intecc Co., Ltd. | 02/25/2016SE |
| K152231 | Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireDQX · Traditional | Boston Scientific Corporation | 02/12/2016SE |
| K152991 | OptoWire DeuxDQX · Traditional | Opsens | 02/11/2016SE |
| K152497 | PW GuidewiresDQX · Traditional | Tatara Vascular, LLC | 01/22/2016SE |
| K151840 | Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…DQX · Traditional | Boston Scientific Corporation | 12/16/2015SE |
| K151234 | R350 guidewireDQX · Traditional | Vascular Solutions, Inc. | 11/18/2015SE |
| K152740 | Radifocus GlidewireDQX · Traditional | Ashitaka Factory of Terumo Corp. | 11/16/2015SE |
| K152709 | Hi-Torque BalanceDQX · Special | Abbott Vascular | 10/21/2015SE |
| K152404 | Hi-Torque Command 18 Guide WireDQX · Special | Abbott Vascular | 09/21/2015SE |
| K150465 | Medtronic Confida Brecker GuidewireDQX · Traditional | Medtronic Core Valve, LLC | 08/03/2015SE |
| K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)DQX · Traditional | Asahi Intecc Co., Ltd. | 06/30/2015SE |
| K142598 | Opto Wire and OptoMonitor SystemDQX · Traditional | Opsens, Inc. | 06/12/2015SE |
| K151244 | Pre-Formed GuidewireDQX · Special | Lake Region Medical | 06/11/2015SE |
| K150802 | Heavy Double Flexible Tipped Wire GuideDQX · Traditional | Cook Incorporated | 05/28/2015SE |
| K143252 | Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)DQX · Traditional | Needle Tech Products, Inc. | 04/23/2015SE |
| K143316 | Attain Hybrid Guide WireDQX · Traditional | Medtronic, Inc. | 03/11/2015SE |
| K143135 | Spring Coil GuidewireDQX · Traditional | Neometrics, Inc. | 02/20/2015SE |
| K141707 | Ultraskin Hydrophilic Guide WireDQX · Traditional | Lepu Medical Technology (Beijing) Co., Ltd. | 01/21/2015SE |
| K143587 | ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…DQX · Special | Boston Scientific Corporation | 01/15/2015SE |
| K142415 | Hi-Torque JET Guide Wire FamilyDQX · Traditional | Abbott Vascular, Inc. | 12/19/2014SE |
| K141218 | Zigiwire MODE2 Guidewire Wire System, Zigiwire MODE3 Guidewire Wire SystemDQX · Traditional | Vadiswire Corporation | 12/18/2014SE |
| K142051 | Prelude Plastic Jacketed Guide WireDQX · Traditional | Merit Medical Systems, Inc. | 12/17/2014SE |
| K140536 | Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250T…DQX · Traditional | Lake Region Medical | 12/17/2014SE |
| K141295 | Merit Hydrophilic GuidewireDQX · Traditional | Merit Medical Systems, Inc. | 12/16/2014SE |
| K141054 | Distal Access Torque DeviceDQX · Traditional | Distal Access, LLC | 12/10/2014SE |
| K142393 | Predicate III GuidewireDQX · Special | Lake Region Medical | 11/25/2014SE |
| K142254 | CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…DQX · Special | St Jude Medical | 11/13/2014SE |
| K141339 | Asahi RG3 Guidewire/Asahi RG3 Soft GuidewireDQX · Traditional | Asahi Intecc Co., Ltd. | 10/23/2014SE |
| K140608 | Merit Heparin-Coated Inqwire Diagnostic GuidewireDQX · Special | Merit Medical Systems, Inc. | 09/12/2014SE |
| K141831 | Hydraview GuidewireDQX · Traditional | Brivant Limited | 09/04/2014SE |
| K141782 | Hi-Torque Versaturn Guide WireDQX · Special | Abbott Vascular | 08/07/2014SE |
| K140695 | Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition…DQX · Traditional | Medtronic, Inc. | 06/12/2014SE |
| K140673 | Insertion ToolDQX · Special | Boston Scientific Corp | 04/16/2014SE |
| K133155 | Hydrophilic Coated GuidewireDQX · Traditional | Lake Region Medical | 04/07/2014SE |
| K140485 | Mandrel GuidewireDQX · Special | Lake Region Medical | 03/27/2014SE |
| K133865 | Asahi Gaia First, Second, ThirdDQX · Traditional | Asahi Intecc Co., Ltd. | 03/18/2014SE |
| K133396 | Vdrive with V-SonoDQX · Special | Stereotaxis, Inc. | 02/06/2014SE |
| K132623 | Medtronic Confida Brecker Curve GuidewireDQX · Traditional | Medtronic | 12/19/2013SE |
| K133230 | Inqwire Diagnostic Guide WireDQX · Special | Merit Medical Systems, Inc. | 12/12/2013SE |
| K132545 | Medivalve AcwireDQX · Traditional | Medivalve , Ltd. | 11/08/2013SE |
| K123792 | Horizon Xvu (FFR)DQX · Traditional | Mennen Medical , Ltd. | 08/30/2013SE |
| K130798 | Pre-Formed GuidewiresDQX · Traditional | Lake Region Medical, Inc. | 08/23/2013SE |
| K131710 | Merit Hydrophilic Guide WireDQX · Special | Merit Medical Systems, Inc. | 07/29/2013SE |
| K122659 | Vdrive W/V-SonoDQX · Traditional | Stereotaxis, Inc. | 07/26/2013SE |
| K130766 | Roadrunner Uniglide Hydrophilic Wire GuideDQX · Special | Cook, Inc. | 07/17/2013SE |
| K131288 | Verrata Pressure Guide WireDQX · Special | Volcano Corporation | 06/21/2013SE |
| K130104 | Guidewire, Pursuer SeriesDQX · Traditional | Oscor, Inc. | 06/13/2013SE |
| K130588 | Merit Hydrophilic Guide WireDQX · Special | Merit Medical Systems, Inc. | 04/05/2013SE |
| K122469 | Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJDQX · Special | Asahi Intecc Co., Ltd. | 03/08/2013SE |
| K122468 | Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM…DQX · Special | Asahi Intecc Co., Ltd. | 03/08/2013SE |
| K124007 | Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion…DQX · Traditional | Micro Therapeutics, Inc. D/B/A: Ev3, Inc. | 03/07/2013SE |
| K122590 | Radifocus Glidewire Advantage, Radifocus Glidewire AdvantageDQX · Special | Terumo Medical Corporation | 03/01/2013SE |
| K123707 | Alight 16 Superselective Microwire GuideDQX · Special | Cook, Inc. | 02/28/2013SE |
| K123067 | Progress Guide Wire Family, Pilot Guide Wire FamilyDQX · Traditional | Abbott Vascular, Inc. | 01/29/2013SE |
| K123609 | Merit Hydrophilic Guide WireDQX · Special | Merit Medical Systems, Inc. | 01/16/2013SE |
| K121398 | Charlie Guidewire (Regular), Charlie Guidewire (Stiff)DQX · Traditional | Guidepath Medical, Inc. | 12/13/2012SE |
| K122573 | Hi-Torque Command Guide Wire FamilyDQX · Traditional | Abbott Vascular, Inc. | 11/20/2012SE |
| K122795 | Stingray GuidewiresDQX · Special | Bridgepoint Medical | 11/08/2012SE |
| K123024 | Torque DeviceDQX · Special | Boston Scientific Corporation | 10/26/2012SE |
| K122856 | Charter GuidewireDQX · Special | Brivant, Ltd. | 10/17/2012SE |
| K122089 | Ostial Pro Stent Positioning SystemDQX · Special | Merit Medical Systems, Inc. | 09/21/2012SE |
| K120644 | Merit Hydrophilic Guide WireDQX · Traditional | Merit Medical Systems, Inc. | 09/19/2012SE |
| K122506 | Surefire High Flow Angiographic Catheter, AccessDQX · Traditional | Surefire Medical, Inc. | 09/17/2012SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2917-2026 Class II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP…Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of… | Galt Medical Corporation | 06/26/2026Open, Classified |
| Z-2517-2026 Class II | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645…Due to unsealed portions of pouches. | Merit Medical Systems, Inc. | 05/08/2026Open, Classified |
| Z-2397-2026 Class I | Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-1777-2026 Class II | COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Cook Incorporated | 03/05/2026Open, Classified |
| Z-1776-2026 Class II | COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Cook Incorporated | 03/05/2026Open, Classified |
| Z-1775-2026 Class II | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Cook Incorporated | 03/05/2026Open, Classified |
| Z-1829-2026 Class II | Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | Medline Industries, LP | 02/25/2026Open, Classified |
| Z-1734-2025 Class II | GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous…Due to a potential open seal in the sterile barrier packaging. | Galt Medical Corporation | 03/27/2025Open, Classified |
| Z-0499-2025 Class II | Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789Devices from the affected device lots have labels that state the incorrect expiration dates. | Cook Incorporated | 10/14/2024Open, Classified |
| Z-0347-2025 Class II | Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers:…Affected device lots have labels that state the incorrect expiration dates. | Cook Incorporated | 10/08/2024Open, Classified |
| Z-0346-2025 Class II | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers:…Affected device lots have labels that state the incorrect expiration dates. | Cook Incorporated | 10/08/2024Open, Classified |
| Z-3299-2024 Class II | Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025"…Reports have been received regarding open seals on the packaging. | ARROW INTERNATIONAL Inc. | 07/26/2024Open, Classified |
| Z-3062-2024 Class II | Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with…Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop… | Bard Peripheral Vascular Inc | 07/10/2024Open, Classified |
| Z-1909-2024 Class II | Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm…Neurovascular devices did not meet the minimum sample size required for endotoxin testing during… | Stryker Neurovascular | 04/23/2024Open, Classified |
| Z-1941-2024 Class II | The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are…Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro… | Stryker Neurovascular | 04/18/2024Open, Classified |
| Z-1939-2024 Class II | The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The…Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro… | Stryker Neurovascular | 04/18/2024Open, Classified |
| Z-1267-2024 Class I | ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a)…Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received… | ARROW INTERNATIONAL Inc. | 02/12/2024Open, Classified |
| Z-1847-2022 Class II | Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1846-2022 Class II | Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1845-2022 Class II | Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1843-2022 Class II | Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1842-2022 Class II | Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1841-2022 Class II | Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1840-2022 Class II | Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1839-2022 Class II | Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1838-2022 Class II | Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1836-2022 Class II | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1835-2022 Class II | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1834-2022 Class II | Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1833-2022 Class II | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1832-2022 Class II | Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1831-2022 Class II | Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1830-2022 Class II | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1829-2022 Class II | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1828-2022 Class II | Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1827-2022 Class II | Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1826-2022 Class II | Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1825-2022 Class II | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip)…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1824-2022 Class II | Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number:…Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron… | Cook Incorporated | 08/16/2022Open, Classified |
| Z-1718-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1717-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1716-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1715-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1714-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1713-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1712-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1711-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1710-2022 Class II | Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1709-2022 Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |
| Z-1708-2022 Class II | Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER…Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration… | Cook Incorporated | 07/19/2022Open, Classified |