Panels › Cardiovascular › Product code DRA · Class 2
Catheter, Steerable
Regulation 870.1280
1510(k)s in 12 months (42 all time)
4recalls in 12 months (10 all time)
9recalls that name a 510(k)
Top companies in DRA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K262165 | FARADRIVE Steerable Sheath (M004PF21M402) Boston Scientific Corporation | DRA |
| Jun 3, 2025 | K250529 | Globe Introducer (601-01001) Kardium, Inc., CA | DRA |
| Dec 11, 2023 | K233248 | FARADRIVE Steerable Sheath Boston Scientific Corporation | DRA |
| Oct 31, 2023 | K232321 | FlexCath Contour Steerable Sheath Medtronic, Inc. | DRA |
| Mar 22, 2023 | K223824 | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP Boston Scientific Corporation | DRA |
| Sep 28, 2022 | K221397 | MitraClip G4 Steerable Guide Catheter ABBOTT MEDICAL | DRA |
| May 5, 2022 | K221044 | AcQGuide® VUE Steerable Sheath Acutus Medical, Inc. | DRA |
| May 14, 2021 | K211100 | AcQGuide MAX Steerable Sheath Acutus Medical, Inc. | DRA |
| Nov 13, 2020 | K202620 | FlexCath Advance Steerable Sheath and Dilator Medtronic Cryocath, LP | DRA |
| Oct 4, 2019 | K192422 | Steerable Introducer 12F Freudenberg Medical, LLC | DRA |
| May 29, 2019 | K190167 | MitraClip G4 Steerable Guide Catheter Abbott | DRA |
| Nov 26, 2018 | K183174 | FlexCath Advance Steerable Sheath and Dilator Medtronic Cryocath, LP | DRA |
| Sep 6, 2017 | K172394 | Steerable Guide Catheter Abbott Vascular | DRA |
| Apr 6, 2017 | K162925 | AcQGuide Steerable Sheath Acutus Medical, Inc. | DRA |
| Sep 20, 2016 | K160919 | Hansen Medical Magellan Robotic Catheter 9Fr Hansen Medical, Inc. | DRA |
| Aug 7, 2016 | K161985 | Steerable Guide Catheter Abbott Vascular | DRA |
| Feb 24, 2016 | K152310 | HeartLight Deflectable Sheath Cardiofocus, Inc. | DRA |
| Feb 1, 2016 | K153304 | Hansen Medical Magellan Robotic Catheter eKit Hansen Medical, Inc. | DRA |
| Aug 18, 2015 | K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components Hansen Medical, Inc. | DRA |
| Feb 7, 2014 | K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT Hansen Medical | DRA |
| Dec 27, 2012 | K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) Medtronic Cryocath, LP | DRA |
| Aug 29, 2012 | K122275 | ARTISAN EXTEND CONTROL CATHETER Hansen Medical | DRA |
| Apr 24, 2012 | K120086 | CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM Cardiosolutions | DRA |
| Feb 7, 2012 | K112541 | Z FLEX-270TM STEERABLE SHEATH Great Batch Medical | DRA |
| Aug 31, 2011 | K112239 | STEERABLE GUIDE CATHETER Abbott Vascular | DRA |
| Sep 1, 2010 | K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 Medtronic Cryocath, LP, CA | DRA |
| Apr 21, 2010 | K100789 | MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST Evalve, Inc. | DRA |
| Jan 13, 2010 | K093866 | EVALVE STEERABLE GUIDE CATHETER Evalve, Inc. | DRA |
| Jul 2, 2009 | K091596 | EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST Evalve, Inc. | DRA |
| Apr 27, 2009 | K083793 | STEERABLE GUIDE CATHETER Evalve, Inc. | DRA |
| Jun 27, 2008 | K081049 | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 Cryocath Technologies, Inc. | DRA |
| Dec 28, 2007 | K070357 | FLEXCATH STEERABLE SHEATH & DILATOR Cryocath Technologies, Inc. | DRA |
| Jan 19, 2006 | K052575 | LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN St Jude Medical | DRA |
| Mar 11, 2005 | K050472 | LYSUS INFUSION SYSTEM Ekos Corp. | DRA |
| May 12, 2004 | K040165 | REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 St Jude Medical | DRA |
| Oct 24, 2001 | K012143 | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 Medtronic Cardiac Surgical Products | DRA |
| Jun 29, 1993 | K924227 | CRI CYNOSAR CATHETER Catheter Research C/O Burditt, Bowles & Radzius | DRA |
| Jan 26, 1993 | K913940 | RESPONSE(TM) STEERABLE CATHETER Daig Corp. | DRA |
| Mar 6, 1991 | K904785 | CRI CYNOSAR CATHETER Catheter Research C/O Burditt, Bowles & Radzius | DRA |
| Sep 14, 1990 | K900320 | CRI CYNOSAR CATHETER Catheter Research C/O Burditt, Bowles & Radzius | DRA |
| Jan 5, 1989 | K884337 | MICRO-GUIDE SYSTEM Catheter Research C/O Burditt, Bowles & Radzius | DRA |
| Jan 27, 1984 | K834352 | ADULT VENT CATHETER Dlp, Inc. | DRA |
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