FDA 510(k) Applications for Medical Device Product Code "DRA"
(Catheter, Steerable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K190167 | Abbott | MitraClip G4 Steerable Guide Catheter | 05/29/2019 |
| K221397 | Abbott Medical | MitraClip G4 Steerable Guide Catheter | 09/28/2022 |
| K161985 | ABBOTT VASCULAR | Steerable Guide Catheter | 08/07/2016 |
| K172394 | Abbott Vascular | Steerable Guide Catheter | 09/06/2017 |
| K112239 | Abbott Vascular | STEERABLE GUIDE CATHETER | 08/31/2011 |
| K211100 | Acutus Medical, Inc. | AcQGuide MAX Steerable Sheath | 05/14/2021 |
| K162925 | ACUTUS MEDICAL, INC. | AcQGuide Steerable Sheath | 04/06/2017 |
| K221044 | Acutus Medical, Inc. | AcQGuide« VUE Steerable Sheath | 05/05/2022 |
| K233248 | Boston Scientific Corporation | FARADRIVEÖ Steerable Sheath | 12/11/2023 |
| K223824 | Boston Scientific Corporation | POLARSHEATHÖ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAPÖ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAPÖ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZEÖ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZEÖ Esophageal Temperature S | 03/22/2023 |
| K152310 | CARDIOFOCUS, INC. | HeartLight Deflectable Sheath | 02/24/2016 |
| K120086 | CARDIOSOLUTIONS | CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM | 04/24/2012 |
| K070357 | CRYOCATH TECHNOLOGIES, INC. | FLEXCATH STEERABLE SHEATH & DILATOR | 12/28/2007 |
| K081049 | CRYOCATH TECHNOLOGIES, INC. | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 | 06/27/2008 |
| K050472 | EKOS CORP. | LYSUS INFUSION SYSTEM | 03/11/2005 |
| K093866 | EVALVE INC | EVALVE STEERABLE GUIDE CATHETER | 01/13/2010 |
| K091596 | EVALVE INC | EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST | 07/02/2009 |
| K100789 | EVALVE INC | MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST | 04/21/2010 |
| K083793 | EVALVE INC | STEERABLE GUIDE CATHETER | 04/27/2009 |
| K192422 | Freudenberg Medical LLC | Steerable Introducer 12F | 10/04/2019 |
| K112541 | Greatbatch Medical | Z FLEX-270TM STEERABLE SHEATH | 02/07/2012 |
| K122275 | Hansen Medical | ARTISAN EXTEND CONTROL CATHETER | 08/29/2012 |
| K133552 | Hansen Medical | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | 02/07/2014 |
| K151463 | HANSEN MEDICAL, INC. | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | 08/18/2015 |
| K160919 | HANSEN MEDICAL, INC. | Hansen Medical Magellan Robotic Catheter 9Fr | 09/20/2016 |
| K153304 | Hansen Medical, Inc. | Hansen Medical Magellan Robotic Catheter eKit | 02/01/2016 |
| K250529 | Kardium Inc. | Globe Introducer (601-01001) | 06/03/2025 |
| K012143 | MEDTRONIC CARDIAC SURGICAL PRODUCTS | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 | 10/24/2001 |
| K123591 | MEDTRONIC CRYOCATH LP | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | 12/27/2012 |
| K183174 | Medtronic CryoCath LP | FlexCath Advance Steerable Sheath and Dilator | 11/26/2018 |
| K202620 | Medtronic CryoCath LP | FlexCath Advance Steerable Sheath and Dilator | 11/13/2020 |
| K102176 | MEDTRONIC CRYOCATH LP | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 | 09/01/2010 |
| K232321 | Medtronic Inc. | FlexCath ContourÖ Steerable Sheath | 10/31/2023 |
| K052575 | ST. JUDE MEDICAL | LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN | 01/19/2006 |
| K040165 | ST. JUDE MEDICAL | REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 | 05/12/2004 |
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