Catheter, Steerable
FDA product code DRA · Class II (moderate risk) · 21 CFR 870.1280 · Cardiovascular
42510(k) clearances
0PMA approvals
10recalls
Manufacturers
- Hansen Medical, Inc. 5
- Catheter Research C/O Burditt, Bowles & Radzius 4
- Evalve, Inc. 4
- Medtronic Cryocath, LP 4
- Boston Scientific Corporation 3
- Abbott Vascular 3
- Acutus Medical, Inc. 3
- St Jude Medical 2
- Cryocath Technologies, Inc. 2
- Kardium, Inc. 1
- Dlp, Inc. 1
- Medtronic, Inc. 1
- Abbott Medical 1
- Freudenberg Medical, LLC 1
- Abbott 1
- Cardiofocus, Inc. 1
- Cardiosolutions, Inc. 1
- Great Batch Medical 1
- Ekos Corp. 1
- Medtronic Cardiac Surgical Products 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | Boston Scientific Corporation | 07/24/2026SE |
| K250529 | Globe Introducer (601-01001)DRA · Traditional | Kardium, Inc. | 06/03/2025SE |
| K233248 | FARADRIVE Steerable SheathDRA · Traditional | Boston Scientific Corporation | 12/11/2023SE |
| K232321 | FlexCath Contour Steerable SheathDRA · Traditional | Medtronic, Inc. | 10/31/2023SE |
| K223824 | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping…DRA · Traditional | Boston Scientific Corporation | 03/22/2023SE |
| K221397 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott Medical | 09/28/2022SE |
| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/05/2022SE |
| K211100 | AcQGuide MAX Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/14/2021SE |
| K202620 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | Medtronic Cryocath, LP | 11/13/2020SE |
| K192422 | Steerable Introducer 12FDRA · Traditional | Freudenberg Medical, LLC | 10/04/2019SE |
| K190167 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott | 05/29/2019SE |
| K183174 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | Medtronic Cryocath, LP | 11/26/2018SE |
| K172394 | Steerable Guide CatheterDRA · Special | Abbott Vascular | 09/06/2017SE |
| K162925 | AcQGuide Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 04/06/2017SE |
| K160919 | Hansen Medical Magellan Robotic Catheter 9FrDRA · Traditional | Hansen Medical, Inc. | 09/20/2016SE |
| K161985 | Steerable Guide CatheterDRA · Special | Abbott Vascular | 08/07/2016SE |
| K152310 | HeartLight Deflectable SheathDRA · Traditional | Cardiofocus, Inc. | 02/24/2016SE |
| K153304 | Hansen Medical Magellan Robotic Catheter eKitDRA · Traditional | Hansen Medical, Inc. | 02/01/2016SE |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory ComponentsDRA · Special | Hansen Medical, Inc. | 08/18/2015SE |
| K133552 | Magellan Robotic Catheter 6FR (Guide and Leader), Magellan Robotic Catheter 6FR…DRA · Special | Hansen Medical | 02/07/2014SE |
| K123591 | Flexcath Advance Steerable Sheath (12 French)DRA · Special | Medtronic Cryocath, LP | 12/27/2012SE |
| K122275 | Artisan Extend Control CatheterDRA · Special | Hansen Medical | 08/29/2012SE |
| K120086 | Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…DRA · Traditional | Cardiosolutions | 04/24/2012SE |
| K112541 | Z FLEX-270TM Steerable SheathDRA · Traditional | Great Batch Medical | 02/07/2012SE |
| K112239 | Steerable Guide CatheterDRA · Special | Abbott Vascular | 08/31/2011SE |
| K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model…DRA · Special | Medtronic Cryocath, LP | 09/01/2010SE |
| K100789 | Modificaton to: Steerable Guide Catheter, Model SGC01STDRA · Special | Evalve, Inc. | 04/21/2010SE |
| K093866 | Evalve Steerable Guide CatheterDRA · Special | Evalve, Inc. | 01/13/2010SE |
| K091596 | Evalve Steerable Guide Catheter, Model SGC01STDRA · Special | Evalve, Inc. | 07/02/2009SE |
| K083793 | Steerable Guide CatheterDRA · Traditional | Evalve, Inc. | 04/27/2009SE |
| K081049 | Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12DRA · Special | Cryocath Technologies, Inc. | 06/27/2008SE |
| K070357 | Flexcath Steerable Sheath & DilatorDRA · Traditional | Cryocath Technologies, Inc. | 12/28/2007SE |
| K052575 | Luminary Cannulator Bideflectable Catheter with LumenDRA · Traditional | St Jude Medical | 01/19/2006SE |
| K050472 | Lysus Infusion SystemDRA · Special | Ekos Corp. | 03/11/2005SE |
| K040165 | Reflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model 402805DRA · Traditional | St Jude Medical | 05/12/2004SE |
| K012143 | 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524DRA · Special | Medtronic Cardiac Surgical Products | 10/24/2001SE |
| K924227 | Cri Cynosar CatheterDRA · Traditional | Catheter Research C/O Burditt, Bowles & Radzius | 06/29/1993SE |
| K913940 | Response(Tm) Steerable CatheterDRA · Traditional | Daig Corp. | 01/26/1993SE |
| K904785 | Cri Cynosar CatheterDRA · Traditional | Catheter Research C/O Burditt, Bowles & Radzius | 03/06/1991SE |
| K900320 | Cri Cynosar CatheterDRA · Traditional | Catheter Research C/O Burditt, Bowles & Radzius | 09/14/1990SE |
| K884337 | Micro-Guide SystemDRA · Traditional | Catheter Research C/O Burditt, Bowles & Radzius | 01/05/1989SE |
| K834352 | Adult Vent CatheterDRA · Traditional | Dlp, Inc. | 01/27/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2757-2026 Class II | FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2756-2026 Class II | FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2755-2026 Class II | FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2754-2026 Class II | FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-1302-2024 Class I | Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the… | Boston Scientific Corporation | 02/12/2024Open, Classified |
| Z-2505-2021 Class II | DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx OnlyPotential for a wire protrusion through the left heart vent catheter tip | Medtronic Perfusion Systems | 08/24/2021Open, Classified |
| Z-2504-2021 Class II | DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx OnlyPotential for a wire protrusion through the left heart vent catheter tip | Medtronic Perfusion Systems | 08/24/2021Open, Classified |
| Z-2459-2012 Class II | Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by…During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac… | Greatbatch Medical | 09/06/2012Terminated |
| Z-3186-2011 | Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a…Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic… | Medtronic Inc. Cardiac Rhythm Disease… | 07/15/2011Terminated |
| Z-2106-2008 | Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc.…The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of… | Hansen Medical Inc | 05/21/2008Terminated |