FDA Product Code
FDA Product Code DRA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1280
510(k) Clearances — 42 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | 2026-07-24 | Special | PDF ↗ |
| K250529 | Globe Introducer (601-01001) | Kardium, Inc. | 2025-06-03 | Traditional | PDF ↗ |
| K233248 | FARADRIVE Steerable Sheath | Boston Scientific Corporation | 2023-12-11 | Traditional | PDF ↗ |
| K232321 | FlexCath Contour Steerable Sheath | Medtronic, Inc. | 2023-10-31 | Traditional | PDF ↗ |
| 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 Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor | Boston Scientific Corporation | 2023-03-22 | Traditional | PDF ↗ |
| K221397 | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | 2022-09-28 | Special | PDF ↗ |
| K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | 2022-05-05 | Traditional | PDF ↗ |
| K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | 2021-05-14 | Traditional | PDF ↗ |
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2020-11-13 | Traditional | PDF ↗ |
| K192422 | Steerable Introducer 12F | Freudenberg Medical, LLC | 2019-10-04 | Traditional | PDF ↗ |
| K190167 | MitraClip G4 Steerable Guide Catheter | Abbott | 2019-05-29 | Special | PDF ↗ |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2018-11-26 | Traditional | PDF ↗ |
| K172394 | Steerable Guide Catheter | Abbott Vascular | 2017-09-06 | Special | PDF ↗ |
| K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | 2017-04-06 | Traditional | PDF ↗ |
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | 2016-09-20 | Traditional | PDF ↗ |
| K161985 | Steerable Guide Catheter | Abbott Vascular | 2016-08-07 | Special | PDF ↗ |
| K152310 | HeartLight Deflectable Sheath | Cardiofocus, Inc. | 2016-02-24 | Traditional | PDF ↗ |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | 2016-02-01 | Traditional | PDF ↗ |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | 2015-08-18 | Special | PDF ↗ |
| K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | Hansen Medical | 2014-02-07 | Special | PDF ↗ |
| K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | Medtronic Cryocath, LP | 2012-12-27 | Special | PDF ↗ |
| K122275 | ARTISAN EXTEND CONTROL CATHETER | Hansen Medical | 2012-08-29 | Special | PDF ↗ |
| K120086 | CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM | Cardiosolutions | 2012-04-24 | Traditional | PDF ↗ |
| K112541 | Z FLEX-270TM STEERABLE SHEATH | Great Batch Medical | 2012-02-07 | Traditional | PDF ↗ |
| K112239 | STEERABLE GUIDE CATHETER | Abbott Vascular | 2011-08-31 | Special | PDF ↗ |
| K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 | Medtronic Cryocath, LP | 2010-09-01 | Special | PDF ↗ |
| K100789 | MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST | Evalve, Inc. | 2010-04-21 | Special | PDF ↗ |
| K093866 | EVALVE STEERABLE GUIDE CATHETER | Evalve, Inc. | 2010-01-13 | Special | PDF ↗ |
| K091596 | EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST | Evalve, Inc. | 2009-07-02 | Special | PDF ↗ |
| K083793 | STEERABLE GUIDE CATHETER | Evalve, Inc. | 2009-04-27 | Traditional | PDF ↗ |
| K081049 | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008-06-27 | Special | PDF ↗ |
| K070357 | FLEXCATH STEERABLE SHEATH & DILATOR | Cryocath Technologies, Inc. | 2007-12-28 | Traditional | PDF ↗ |
| K052575 | LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN | St Jude Medical | 2006-01-19 | Traditional | PDF ↗ |
| K050472 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-03-11 | Special | PDF ↗ |
| K040165 | REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 | St Jude Medical | 2004-05-12 | Traditional | PDF ↗ |
| K012143 | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 | Medtronic Cardiac Surgical Products | 2001-10-24 | Special | PDF ↗ |
| K924227 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1993-06-29 | Traditional | PDF ↗ |
| K913940 | RESPONSE(TM) STEERABLE CATHETER | Daig Corp. | 1993-01-26 | Traditional | PDF ↗ |
| K904785 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1991-03-06 | Traditional | PDF ↗ |
| K900320 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1990-09-14 | Traditional | PDF ↗ |
| K884337 | MICRO-GUIDE SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | 1989-01-05 | Traditional | PDF ↗ |
| K834352 | ADULT VENT CATHETER | Dlp, Inc. | 1984-01-27 | Traditional | PDF ↗ |
Product code DRA · Class II · Cardiovascular. Data: openFDA.