| FARADRIVE™ Steerable Sheath (M004PF21M402) (K262165) | Boston Scientific Corporation | 2026-07-24 |
| Globe Introducer (601-01001) (K250529) | Kardium, Inc. | 2025-06-03 |
| FARADRIVE™ Steerable Sheath (K233248) | Boston Scientific Corporation | 2023-12-11 |
| FlexCath Contour™ Steerable Sheath (K232321) | Medtronic, Inc. | 2023-10-31 |
| 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 (K223824) | Boston Scientific Corporation | 2023-03-22 |
| MitraClip G4 Steerable Guide Catheter (K221397) | ABBOTT MEDICAL | 2022-09-28 |
| AcQGuide® VUE Steerable Sheath (K221044) | Acutus Medical, Inc. | 2022-05-05 |
| AcQGuide MAX Steerable Sheath (K211100) | Acutus Medical, Inc. | 2021-05-14 |
| FlexCath Advance Steerable Sheath and Dilator (K202620) | Medtronic Cryocath, LP | 2020-11-13 |
| Steerable Introducer 12F (K192422) | Freudenberg Medical, LLC | 2019-10-04 |
| MitraClip G4 Steerable Guide Catheter (K190167) | Abbott | 2019-05-29 |
| FlexCath Advance Steerable Sheath and Dilator (K183174) | Medtronic Cryocath, LP | 2018-11-26 |
| Steerable Guide Catheter (K172394) | Abbott Vascular | 2017-09-06 |
| AcQGuide Steerable Sheath (K162925) | Acutus Medical, Inc. | 2017-04-06 |
| Hansen Medical Magellan Robotic Catheter 9Fr (K160919) | Hansen Medical, Inc. | 2016-09-20 |
| Steerable Guide Catheter (K161985) | Abbott Vascular | 2016-08-07 |
| HeartLight Deflectable Sheath (K152310) | Cardiofocus, Inc. | 2016-02-24 |
| Hansen Medical Magellan Robotic Catheter eKit (K153304) | Hansen Medical, Inc. | 2016-02-01 |
| Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components (K151463) | Hansen Medical, Inc. | 2015-08-18 |
| MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT (K133552) | Hansen Medical | 2014-02-07 |
| FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) (K123591) | Medtronic Cryocath, LP | 2012-12-27 |
| ARTISAN EXTEND CONTROL CATHETER (K122275) | Hansen Medical | 2012-08-29 |
| CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM (K120086) | Cardiosolutions | 2012-04-24 |
| Z FLEX-270TM STEERABLE SHEATH (K112541) | Great Batch Medical | 2012-02-07 |
| STEERABLE GUIDE CATHETER (K112239) | Abbott Vascular | 2011-08-31 |
| FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 (K102176) | Medtronic Cryocath, LP | 2010-09-01 |
| MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST (K100789) | Evalve, Inc. | 2010-04-21 |
| EVALVE STEERABLE GUIDE CATHETER (K093866) | Evalve, Inc. | 2010-01-13 |
| EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST (K091596) | Evalve, Inc. | 2009-07-02 |
| STEERABLE GUIDE CATHETER (K083793) | Evalve, Inc. | 2009-04-27 |
| FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 (K081049) | Cryocath Technologies, Inc. | 2008-06-27 |
| FLEXCATH STEERABLE SHEATH & DILATOR (K070357) | Cryocath Technologies, Inc. | 2007-12-28 |
| LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN (K052575) | St Jude Medical | 2006-01-19 |
| LYSUS INFUSION SYSTEM (K050472) | Ekos Corp. | 2005-03-11 |
| REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805 (K040165) | St Jude Medical | 2004-05-12 |
| 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 (K012143) | Medtronic Cardiac Surgical Products | 2001-10-24 |
| CRI CYNOSAR CATHETER (K924227) | Catheter Research C/O Burditt, Bowles & Radzius | 1993-06-29 |
| RESPONSE(TM) STEERABLE CATHETER (K913940) | Daig Corp. | 1993-01-26 |
| CRI CYNOSAR CATHETER (K904785) | Catheter Research C/O Burditt, Bowles & Radzius | 1991-03-06 |
| CRI CYNOSAR CATHETER (K900320) | Catheter Research C/O Burditt, Bowles & Radzius | 1990-09-14 |
| MICRO-GUIDE SYSTEM (K884337) | Catheter Research C/O Burditt, Bowles & Radzius | 1989-01-05 |
| ADULT VENT CATHETER (K834352) | Dlp, Inc. | 1984-01-27 |