Dilator, Vessel, For Percutaneous Catheterization
FDA product code DRE · Class II (moderate risk) · 21 CFR 870.1310 · Cardiovascular
105510(k) clearances
0PMA approvals
32recalls
Manufacturers
- Merit Medical Systems, Inc. 10
- Spectranetics Corp. 9
- Baylis Medical Co., Inc. 5
- Cook Vascular, Inc. 4
- Togo Medikit Co., Ltd. 3
- Galt Medical Corporation 3
- Cook, Inc. 3
- Vascumetrix, LLC 3
- Quinton, Inc. 3
- Med Institute, Inc. 2
- Navilyst Medical, Inc 2
- Uresil Corp. 2
- Professional Medical Services 2
- Arstasis, Inc. 2
- Medi-Plast Intl., Inc. 1
- Mallinckrodt Critical Care 1
- Medrad, Inc. 1
- Sorin Group Italia S.R.L. 1
- Procedure Products, Inc. 1
- Stanco Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
| K210734 | Endovascular Dilator and SetsDRE · Special | Cook Incorporated | 04/06/2021SE |
| K201288 | ExpanSure Large Access Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 06/12/2020SE |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F…DRE · Traditional | Medron, LLC | 05/06/2020SE |
| K200379 | Super SheathDRE · Special | Togo Medikit Co., Ltd. | 03/19/2020SE |
| K192195 | Sterile DilatorDRE · Special | Galt Medical Corp. | 09/26/2019SE |
| K190175 | S-Mak XLDRE · Traditional | Merit Medical Systems, Inc. | 04/10/2019SE |
| K182064 | ExpanSure Transseptal Dilation SystemDRE · Traditional | Baylis Medical Company, Inc. | 03/21/2019SE |
| K183036 | Dilator SetsDRE · Traditional | Cook Incorporated | 12/20/2018SE |
| K182914 | MC3 Vascular Access Kit 21030DRE · Traditional | Mc3 Incorporated | 10/29/2018SE |
| K172487 | Coaxial Dilator Set (Micro-Introducer)DRE · Traditional | Galt Medical Corp. | 10/16/2017SESK |
| K162389 | Medcomp Vessel DilatorDRE · Traditional | Medcomp ( Medical Components) | 06/01/2017SE |
| K170616 | van Andel Dilatation CatheterDRE · Traditional | Cook Incorporated | 04/28/2017SE |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetDRE · Traditional | Cardiacassist, Inc. | 01/06/2017SE |
| K161336 | VSI StraitSet micro-introducer kitDRE · Traditional | Vascular Solutions, Inc. | 08/11/2016SE |
| K150932 | Sheath IntroducerDRE · Traditional | Bioteque Corp. | 07/22/2016SE |
| K161333 | TightRail Sub-C Rotating Dilator SheathDRE · Traditional | Spectranetics, Inc. | 07/08/2016SE |
| K151877 | MicroTract Access SystemDRE · Special | Arstasis, Inc. | 08/07/2015SE |
| K151076 | MicroTaper Needle Introducer SetDRE · Traditional | Summit Access, LLC | 05/22/2015SE |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathDRE · Special | Spectranetics, Inc. | 03/04/2015SE |
| K141070 | Super SheathDRE · Traditional | Togo Medikit Co., Ltd. | 01/15/2015SE |
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath…DRE · Traditional | Cook Vascular, Inc. | 11/12/2014SE |
| K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathDRE · Traditional | Spectranetics, Inc. | 09/25/2014SE |
| K141148 | Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL…DRE · Traditional | Cook Vascular, Inc. | 07/01/2014SE |
| K141131 | Tightrail MiniDRE · Special | Spectranetics, Inc. | 05/23/2014SE |
| K140047 | Lexiconture Mechanical Dilator Sheath SetDRE · Traditional | Spectranetics Corp. | 04/09/2014SE |
| K133631 | Lexipliant Dilator Sheath SetDRE · Traditional | Spectranetics Corporation | 03/27/2014SE |
| K132713 | Nmi Coaxial Microintroducer SetDRE · Special | Navilyst Medical, Inc. | 09/27/2013SE |
| K123842 | Lawmax DilatorDRE · Traditional | Lifetech Scientific (Shenzhen) Co., Ltd. | 06/24/2013SE |
| K130791 | Prelude Sheath IntroducerDRE · Special | Merit Medical Systems, Inc. | 06/07/2013SE |
| K123445 | Nmi Coaxial Microintroducer SetDRE · Traditional | Navilyst Medical, Inc. | 04/01/2013SE |
| K120349 | Sonixgps Vascular Access Needle KitDRE · Traditional | Ultrasonix Medical Corpation | 04/09/2012SE |
| K103421 | Arstasis Dilator AdapterDRE · Traditional | Arstasis, Inc. | 05/24/2011SE |
| K093554 | Retroflex Dilator KitDRE · Traditional | Edwards Lifesciences, LLC | 04/13/2010SE |
| K092378 | Spectranetics Visisheath Dilator SheathDRE · Traditional | Spectranetics Corp. | 11/02/2009SE |
| K091584 | Merit Mak (Mini Access Kit) with Palladium Tip Guide WireDRE · Traditional | Merit Medical Systems, Inc. | 10/09/2009SE |
| K081940 | Avalon Elite Vascular Access KitDRE · Traditional | Avalon Laboratories, LLC | 11/18/2008SE |
| K082075 | Hansen Medical Dilator for Artisan Control CatheterDRE · Special | Hansen Medical, Inc. | 08/15/2008SE |
| K073035 | Prelude and Prelude Pro Sheath IntroducersDRE · Special | Merit Medical Systems, Inc. | 11/20/2007SE |
| K071330 | Galtstick Introducer SystemDRE · Special | Galt Medical Corp. | 10/31/2007SE |
| K070749 | Estech Percutaneous Insertion Dilator KitDRE · Traditional | Coombs Medical Device Consulting | 10/24/2007SE |
| K070159 | Prelude Sheath IntroducerDRE · Special | Merit Medical Systems, Inc. | 06/21/2007SE |
| K062554 | Starclose Hex-Hub DilatorDRE · Traditional | Abbott Vascular, Inc. | 02/06/2007SE |
| K061000 | Evolution Mechanical Dilator Sheath Set MODELS-LR-EVN-7.0, LR-EVN-9.0DRE · Special | Cook Vascular, Inc. | 05/10/2006SE |
| K052557 | Super Sheath Introducer SheathDRE · Traditional | Togo Medikit Co., Ltd. | 01/17/2006SE |
| K050962 | Merit Prelude Sheath IntroducerDRE · Traditional | Merit Medical Systems, Inc. | 05/06/2005SE |
| K031691 | Merit Mak (Mini Access Kit)DRE · Abbreviated | Merit Medical Systems, Inc. | 09/03/2003SE |
| K030260 | Gelbfish Flex Vascular DilatorDRE · Special | Vascumetrix, LLC | 02/20/2003SE |
| K023507 | Modification to Gelbfish Vascular DilatorsDRE · Special | Vascumetrix, LLC | 11/08/2002SE |
| K012256 | Gelbish Vascular DilatorDRE · Traditional | Vascumetrix, LLC | 12/20/2001SE |
| K010055 | Cook Vascular Electrosurgical Dissection SheathDRE · Traditional | Cook Vascular, Inc. | 06/14/2001SE |
| K000737 | Coaxial Dilator SetDRE · Traditional | Xentek Medical, Inc. | 08/01/2000SE |
| K974617 | Peripheral Vascular DilatorDRE · Traditional | Endovascular Instruments, Inc. | 12/01/1998SE |
| K980282 | Uresil Dilator with Radiopaque MarkerDRE · Traditional | Uresil Corp. | 04/24/1998SE |
| K974640 | Coaxial Dilator SetDRE · Traditional | Boston Scientific Corp | 03/13/1998SE |
| K970470 | Evt Expandable SheathDRE · Traditional | Guidant Cardiac and Vascular Surgery | 07/31/1997SE |
| K970392 | Cordis Avanti+Catheter Sheath Introducer SystemDRE · Traditional | Cordis Corp. | 04/24/1997SE |
| K945586 | Flexible Dilating SheathDRE · Traditional | Med Institute, Inc. | 04/04/1997SE |
| K963388 | Vessel DilatorDRE · Traditional | Maxxim Medical | 03/11/1997SE |
| K960917 | PercuglideDRE · Traditional | Scientific Device Manufacturer, LLC | 07/02/1996SE |
| K914555 | Workstation Femoral Intravascular Retrieval (Modi)DRE · Traditional | Med Institute, Inc. | 01/03/1992SE |
| K913027 | Vessel DilatorDRE · Traditional | Deseret Medical, Inc. | 11/27/1991SE |
| K912050 | Novoste Vessel DilaterDRE · Traditional | Novaste Corp. | 10/09/1991SE |
| K905416 | Vessel DilatorDRE · Traditional | The R Group | 03/25/1991SE |
| K904476 | Vessel DilatorDRE · Traditional | Datascope Corp. | 12/10/1990SE |
| K902469 | Byrd Dilator Sheath Set - TeflonDRE · Traditional | Medical Engineering and Development Institute | 08/23/1990SE |
| K901815 | Modified Sterilization of Intra-Art(Tm) CoronaryDRE · Traditional | Pioneering Technologies, Inc. | 07/03/1990SE |
| K896096 | Solostick (Amplatz Dilator Needle)DRE · Traditional | Microvena Corp. | 04/10/1990SE |
| K894330 | Daig Vessel DilatorDRE · Traditional | Daig Corp. | 09/12/1989SE |
| K882238 | Vessel Dilator and Introducer SheathDRE · Traditional | Ideal Medical, Inc. | 08/25/1988SE |
| K881073 | Shiley Femoral Cannulae Introducer KitDRE · Traditional | Shiley, Inc. | 06/09/1988SE |
| K874738 | 10 and 12 French Vessel DilatorsDRE · Traditional | Impra, Inc. | 05/02/1988SE |
| K875327 | Modified Seldinger Initial Puncture InstrumentDRE · Traditional | Schneider-Shilley (Usa) | 03/25/1988SE |
| K872724 | Sheath/DilatorsDRE · Traditional | Med-West, Inc. | 09/15/1987SE |
| K870413 | Percutaneous Sheath W/Wo Medi. (5,6,7,8,8.5FR)DRE · Traditional | Medical Surgical Concepts, Inc. | 06/01/1987SE |
| K871148 | Uresil Carotid Artery SizersDRE · Traditional | Uresil Corp. | 04/22/1987SE |
| K862288 | Modification of Tissue DilatorDRE · Traditional | Quinton, Inc. | 08/19/1986SE |
| K860161 | Heart Catheterization TrayDRE · Traditional | Medical Design Concepts, Inc. | 05/02/1986SE |
| K850337 | Cardiac Catheterization PackDRE · Traditional | Marwood Medical, Inc. | 02/25/1985SE |
| K843261 | Angiosystems Standard Arteriogram & CardDRE · Traditional | Angiosystems, Inc. | 09/11/1984SE |
| K842113 | Amendment to Angiography Kit W/AdditDRE · Traditional | Mallinckrodt Critical Care | 07/13/1984SE |
| K841995 | 10.5 French Dilator, 15CM, W/Luer LockDRE · Traditional | Quinton, Inc. | 07/02/1984SE |
| K840671 | Cardiac Catheterization PackDRE · Traditional | Professional Medical Services | 03/12/1984SE |
| K840022 | Heart Catheterization Tray SetDRE · Traditional | Medi-Plast Intl., Inc. | 02/04/1984SE |
| K840017 | Vertex Percutaneous Catheter IntroducDRE · Traditional | Professional Medical Services | 02/04/1984SE |
| K833965 | 8 French Dilator 15CM, W/Luer LockDRE · Traditional | Quinton, Inc. | 12/16/1983SE |
| K831190 | Vessel DilatorDRE · Traditional | Medrad, Inc. | 05/09/1983SE |
| K822595 | Vessel DilatorDRE · Traditional | Vertex Medical Corp. | 09/28/1982SE |
| K813461 | Percutaneous Entry Needle, SeldingerDRE · Traditional | Ocean Medical Products, Ltd. | 12/29/1981SE |
| K813125 | Micro Transducer CathetersDRE · Traditional | Honeywell, Inc. | 12/14/1981SE |
| K810859 | Single Use Seldinger/Cournand Perc. NDLDRE · Traditional | Procedure Products, Inc. | 04/11/1981SE |
| K802327 | Sheath Dilator SetDRE · Traditional | Stanco Medical, Inc. | 10/10/1980SE |
| K801113 | Dilator, Vessel, for Perc. Catheter.DRE · Traditional | Alva Medical, Inc. | 07/28/1980SE |
| K800462 | Percutaneous Introducer SetDRE · Traditional | Medical Components, Inc. | 03/19/1980SE |
| K780126 | Dilator, Vessel & Introducer, SheathDRE · Traditional | Argon Medical Corp. | 03/02/1978SE |
| K760403 | Temporary Atrial Electrode KitDRE · Traditional | Usci, Div. C.R. Bard, Inc. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2705-2026 Class I | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascularKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-1732-2025 Class II | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41…Due to a potential open seal in the sterile barrier packaging . | Galt Medical Corporation | 03/27/2025Open, Classified |
| Z-3190-2024 Class II | Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)7F sheath introducers labeled as 7.5F | Merit Medical Systems, Inc. | 08/12/2024Open, Classified |
| Z-1348-2024 Class II | MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1347-2024 Class II | MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1346-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1345-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1344-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1343-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1342-2024 Class II | MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1341-2024 Class II | MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1340-2024 Class II | MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1339-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1338-2024 Class II | MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1337-2024 Class II | MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1336-2024 Class II | MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1335-2024 Class II | MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-1334-2024 Class II | MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous…Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical… | Angiodynamics, Inc. | 01/30/2024Open, Classified |
| Z-2079-2021 Class II | Avanti+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and…The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. | Cordis Corporation | 06/09/2021Terminated |
| Z-1486-2021 Class II | Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization.…On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On… | Cardiac Assist, Inc | 03/19/2021Terminated |
| Z-2806-2020 Class II | ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO…Sterile introducer sheath set manufactured under one lot with different expiration dates. | Argon Medical Devices, Inc | 06/19/2020Terminated |
| Z-1603-2020 Class II | Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle… | Maquet Cardiovascular Us Sales, Llc | 02/20/2020Terminated |
| Z-2561-2018 Class II | 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10…The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced… | Galt Medical Corporation | 05/02/2018Terminated |
| Z-1029-2016 Class II | ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and…The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the… | Argon Medical Devices, Inc | 02/17/2016Terminated |
| Z-1174-2016 Class II | CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath…Incorrect cannula of the sheath introducer (smaller than intended). | Cordis Corporation | 12/31/2015Terminated |
| Z-0355-2016 Class II | U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in…The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire… | Procedure Products, Inc. | 10/27/2015Terminated |
| Z-1826-2015 Class II | Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038…Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038… | Merit Medical Systems, Inc. | 06/04/2015Terminated |
| Z-0264-2012 | Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO…Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath… | Boston Scientific Corporation | 11/03/2011Terminated |
| Z-1738-2010 | CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx..…There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the… | Argon Medical Devices, Inc | 03/29/2010Terminated |
| Z-1592-2010 | Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204.…Potential problem with pouch seal thus affecting sterile product. | Galt Medical Corp | 02/08/2010Terminated |
| Z-0519-2010 | Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035…Potential sterility breach caused by excessive shipment damage. | Merit Medical Systems, Inc. | 09/29/2009Terminated |
| Z-0764-2010 | Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x…One lot of Percutaneous Catheter Introducer Set contained incorrect size needle. | Argon Medical Devices, Inc | 01/06/2009Terminated |