Product code DRA
- Device name
- Catheter, Steerable
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1280
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250529 | Globe Introducer (601-01001) | Kardium, Inc. | 2025-06-03 |
| K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023-12-11 |
| K232321 | FlexCath Contour™ Steerable Sheath | Medtronic, Inc. | 2023-10-31 |
| K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esopha... | Boston Scientific Corporation | 2023-03-22 |
| K221397 | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | 2022-09-28 |
| K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | 2022-05-05 |
| K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | 2021-05-14 |
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2020-11-13 |
| K192422 | Steerable Introducer 12F | Freudenberg Medical, LLC | 2019-10-04 |
| K190167 | MitraClip G4 Steerable Guide Catheter | Abbott | 2019-05-29 |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2018-11-26 |
| K172394 | Steerable Guide Catheter | Abbott Vascular | 2017-09-06 |
| K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | 2017-04-06 |
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | 2016-09-20 |
| K161985 | Steerable Guide Catheter | Abbott Vascular | 2016-08-07 |
| K152310 | HeartLight Deflectable Sheath | Cardiofocus, Inc. | 2016-02-24 |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | 2016-02-01 |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | 2015-08-18 |
| K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | Hansen Medical | 2014-02-07 |
| K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | Medtronic Cryocath, LP | 2012-12-27 |
| K122275 | ARTISAN EXTEND CONTROL CATHETER | Hansen Medical | 2012-08-29 |
| K120086 | CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM | Cardiosolutions | 2012-04-24 |
| K112541 | Z FLEX-270TM STEERABLE SHEATH | Great Batch Medical | 2012-02-07 |
| K112239 | STEERABLE GUIDE CATHETER | Abbott Vascular | 2011-08-31 |
| K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 | Medtronic Cryocath, LP | 2010-09-01 |
| K100789 | MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST | Evalve, Inc. | 2010-04-21 |
| K093866 | EVALVE STEERABLE GUIDE CATHETER | Evalve, Inc. | 2010-01-13 |
| K091596 | EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST | Evalve, Inc. | 2009-07-02 |
| K083793 | STEERABLE GUIDE CATHETER | Evalve, Inc. | 2009-04-27 |
| K081049 | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008-06-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810024670314 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2026-01-12 |
| 00810024670550 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2026-01-12 |
| 00810024670543 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2026-01-12 |
| 00810024670536 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2026-01-12 |
| 00810024671380 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-11-05 |
| 00810024671342 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-11-05 |
| 00810024671359 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-11-05 |
| 00810024671366 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-11-05 |
| 00810024671373 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-11-05 |
| 00810024671250 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-03-11 |
| 00810024671229 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-03-11 |
| 00810024670727 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024671106 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024671090 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670840 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670765 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670758 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670741 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670734 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670710 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670703 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670680 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670581 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670574 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670567 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670529 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670512 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00810024670505 | AuST Steerable Sheath | CENTERPOINT SYSTEMS LLC | 2025-02-03 |
| 00643169688858 | FlexCath™ Select | MEDTRONIC, INC. | 2017-05-19 |
| 08717648195921 | MITRACLIP | ABBOTT VASCULAR | 2014-11-26 |