Mechanical Thrombolysis Catheter
FDA product code QEY · Class II (moderate risk) · 21 CFR 870.5150 · Cardiovascular
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
71510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Ekos Corp. 19
- Bacchus Vascular, Inc. 7
- Angiodynamics, Inc. 6
- Thrombolex, Inc. 6
- Merit Medical Systems, Inc. 5
- Btg International, Inc. 5
- Localmed, Inc. 4
- Omnisonics Medical Technologies 4
- Angiodynamics, Div. E-Z-Em, Inc. 3
- Boston Scientific Corporation 3
- Cordis Corp. 2
- Advanced Catheter Therapies, Inc. 2
- Liquet Medical, Inc. 2
- Id, LLC 1
- Covidien LLC 1
- Argon Medical Devices, Inc 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260149 | Versus Catheter (VS110-9NB)QEY · Special | Liquet Medical, Inc. | 02/17/2026SE |
| K251318 | VariFuse Adjustable Infusion CatheterQEY · Traditional | Argon Medical Devices, Inc. | 01/20/2026SE |
| K241851 | Versus Catheter (VS110-8B)QEY · Traditional | Liquet Medical, Inc. | 11/25/2024SE |
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular CatheterQEY · Special | Thrombolex, Inc. | 07/03/2023SE |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…QEY · Traditional | Thrombolex, Inc. | 04/20/2023SE |
| K220866 | EKOS+ Endovascular DeviceQEY · Special | Boston Scientific | 04/20/2022SE |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular DeviceQEY · Traditional | Boston Scientific Corporation | 12/14/2021SE |
| K211080 | EkoSonic Endovascular DeviceQEY · Traditional | Boston Scientific | 11/19/2021SE |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…QEY · Traditional | Thrombolex, Inc. | 06/10/2021SE |
| K202347 | UNIFUSE Infusion System with Cooper WireQEY · Special | AngioDynamics, Inc. | 09/15/2020SE |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0)QEY · Special | Ekos Corporation | 08/17/2020SE |
| K192864 | UNI*FUSE Infusion System with Cooper WireQEY · Traditional | AngioDynamics, Inc. | 06/01/2020SE |
| K193071 | Bashir Plus Endovascular CatheterQEY · Traditional | Thrombolex, Inc. | 12/17/2019SE |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101QEY · Special | Thrombolex, Inc. | 10/18/2019SE |
| K191119 | EkoSonic Endovascular DeviceQEY · Special | Btg International, Inc. | 08/23/2019SE |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0QEY · Traditional | Btg International, Inc. | 04/05/2019SE |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200QEY · Traditional | Thrombolex, Inc. | 02/25/2019SE |
| K182324 | EkoSonic Endovascular SystemQEY · Special | Btg International, Inc. | 11/26/2018SE |
| K163356 | Pulse* Spray Infusion System, Uni*Fuse Infusion SystemQEY · Traditional | AngioDynamics, Inc. | 05/30/2017SE |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0QEY · Traditional | Btg International, Inc. | 02/24/2017SE |
| K170258 | SpeedLyser Infusion Catheter KitQEY · Special | AngioDynamics, Inc. | 02/21/2017SE |
| K162777 | Squirt Fluid Delivery SystemQEY · Special | Merit Medical Systems, Inc. | 10/31/2016SE |
| K153488 | Occlusion Perfusion CatheterQEY · Traditional | Advanced Catheter Therapies, Inc. | 02/25/2016SE |
| K151554 | Occlusion Perfusion CatheterQEY · Traditional | Advanced Catheter Therapies, Inc. | 09/15/2015SE |
| K140151 | Ekosonic Mach 4 Endovascular Device/Ekosonic Control UnitQEY · Traditional | Btg International, Inc. | 05/21/2014SE |
| K130904 | TRELLIS-8 Peripheral Infusion SystemQEY · Traditional | Covidien | 10/25/2013SE |
| K111705 | Ekosonic Endovascular SystemQEY · Traditional | Ekos Corporation | 08/03/2011SE |
| K083335 | Modified Omniwave Endovascular SystemQEY · Special | Omnisonics Medical Technologies | 12/15/2008SE |
| K082199 | Spiralfuse Peripheral Infusion SystemQEY · Traditional | Bacchus Vascular, Inc. | 10/17/2008SE |
| K081467 | Ekosonic Endovascular System with Rapid Pulse ModulationQEY · Special | Ekos Corp. | 06/26/2008SE |
| K080392 | EndoWave Infusion SystemQEY · Special | Ekos Corp. | 04/30/2008SE |
| K072507 | Endowave Infusion SystemQEY · Special | Ekos Corp. | 10/04/2007SE |
| K071762 | Omniwave Endovascular SystemQEY · Traditional | Omnisonics Medical Technologies | 09/27/2007SE |
| K071933 | Endowave Infusion SystemQEY · Special | Ekos Corp. | 08/10/2007SE |
| K063620 | Ekos Micro-Infusion SystemQEY · Traditional | Ekos Corp. | 08/06/2007SESU |
| K071664 | TRELLIS-6 Peripheral Infusion SystemQEY · Special | Bacchus Vascular, Inc. | 07/13/2007SE |
| K062507 | Micro-Infusion SystemQEY · Special | Ekos Corp. | 11/22/2006SE |
| K060422 | Lysus Infusion SystemQEY · Special | Ekos Corp. | 03/09/2006SE |
| K060084 | Lysus Infusion SystemQEY · Special | Ekos Corp. | 02/07/2006SE |
| K053432 | Ekos Micro-Infusion SystemQEY · Special | Ekos Corp. | 12/30/2005SE |
| K052428 | Resolution Endovascular SystemQEY · Traditional | Omnisonics Medical Technologies | 12/08/2005SE |
| K052071 | Lysus Infusion SystemQEY · Special | Ekos Corp. | 08/16/2005SE |
| K051319 | Lysus Infusion SystemQEY · Special | Ekos Corp. | 06/15/2005SE |
| K050563 | Ekos Peripheral Infusion SystemQEY · Special | Ekos Corp. | 03/29/2005SE |
| K050147 | TRELLIS-8 Peripheral Infusion SystemQEY · Special | Bacchus Vascular, Inc. | 02/03/2005SE |
| K043269 | Lysus Infusion SystemQEY · Special | Ekos Corp. | 12/22/2004SE |
| K042456 | Lysus Infusion SystemQEY · Special | Ekos Corp. | 09/23/2004SE |
| K041705 | Resolution Thrombectomy System, Model EV-2QEY · Traditional | Omnisonics Medical Technologies | 09/01/2004SE |
| K041629 | Lysus Infusion SystemQEY · Traditional | Ekos Corp. | 08/06/2004SE |
| K041517 | InfusioncathQEY · Traditional | Id, LLC | 08/05/2004SE |
| K033443 | Speedlyser Infusion Catheter KitQEY · Special | AngioDynamics, Inc. | 11/19/2003SEKD |
| K033214 | Ekos Peripheral Infusion SystemQEY · Special | Ekos Corp. | 10/14/2003SE |
| K032261 | Trellis Reserve Infusion SystemQEY · Special | Bacchus Vascular, Inc. | 08/22/2003SE |
| K030637 | Ekos Peripheral Infusion SystemQEY · Traditional | Ekos Corp. | 07/22/2003SE |
| K023514 | TRELLIS-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)QEY · Traditional | Bacchus Vascular, Inc. | 12/02/2002SE |
| K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…QEY · Special | Bacchus Vascular, Inc. | 07/03/2002SE |
| K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…QEY · Traditional | Bacchus Vascular, Inc. | 02/11/2002SE |
| K992231 | FOUNTAIN Infusion Catheter and Occluding Guide WireQEY · Special | Merit Medical Systems, Inc. | 07/23/1999SE |
| K991619 | FOUNTAIN Infusion Catheter and Occluding Guide WireQEY · Special | Merit Medical Systems, Inc. | 06/09/1999SE |
| K981417 | Squirt Fluid Delivery SystemQEY · Traditional | Merit Medical Systems, Inc. | 07/17/1998SE |
| K980957 | Kaplan-Simpson Infusasleeve IIQEY · Traditional | Localmed, Inc. | 06/10/1998SE |
| K974067 | Fountain Infusion Catheter and Occluding Guide WireQEY · Traditional | Merit Medical Systems, Inc. | 02/27/1998SE |
| K972175 | Infusasleeve Iia (IS-2A)QEY · Traditional | Localmed, Inc. | 08/28/1997SE |
| K972110 | Cordis Endeavor Infusion CatheterQEY · Traditional | Cordis Corp. | 08/14/1997SE |
| K970842 | Cordis Endeavor Infusion CatheterQEY · Traditional | Cordis Corp. | 05/28/1997SE |
| K961763 | Pulse*Spray Infusion SystemQEY · Traditional | Angiodynamics, Div. E-Z-Em, Inc. | 07/17/1996SE |
| K953384 | Multi Side Hole lnfusion SystemQEY · Traditional | AngioDynamics, Inc. | 12/22/1995SE |
| K952317 | Kaplan-Simpson InfusaSleeve II CatheterQEY · Traditional | Localmed, Inc. | 06/28/1995SE |
| K951509 | Pulse*Spray Infusion SystemQEY · Traditional | Angiodynamics, Div. E-Z-Em, Inc. | 06/16/1995SE |
| K950907 | Pulse*Spray Infusion SystemQEY · Traditional | Angiodynamics, Div. E-Z-Em, Inc. | 05/17/1995SE |
| K950615 | Kaplan-Simpson Infusasleeve CatheterQEY · Traditional | Localmed, Inc. | 04/19/1995SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0629-2024 Class II | Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLYThe sterility of microcatheter and infusion system devices cannot be guaranteed. | Merit Medical Systems, Inc. | 11/06/2023Open, Classified |
| Z-0149-2023 Class II | EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a…Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. | Boston Scientific Corporation | 10/13/2022Open, Classified |
| Z-1492-2022 Class II | EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that…Product may be mislabeled. | Boston Scientific Corporation | 05/25/2022Open, Classified |
| Z-1491-2022 Class II | EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that…Product may be mislabeled. | Boston Scientific Corporation | 05/25/2022Open, Classified |