DRA · Catheter, Steerable
Cardiovascular · 21 CFR 870.1280 · Class 2
Overview
| Product Code | DRA |
|---|---|
| Device Name | Catheter, Steerable |
| Regulation | 21 CFR 870.1280 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250529 | Globe Introducer (601-01001) | Kardium, Inc. | Jun 3, 2025 | SESE |
| K233248 | FARADRIVE Steerable Sheath | Boston Scientific Corporation | Dec 11, 2023 | SESE |
| K232321 | FlexCath Contour Steerable Sheath | Medtronic, Inc. | Oct 31, 2023 | SESE |
| 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 | Mar 22, 2023 | SESE |
| K221397 | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | Sep 28, 2022 | SESE |
| K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | May 5, 2022 | SESE |
| K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | May 14, 2021 | SESE |
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | Nov 13, 2020 | SESE |
| K192422 | Steerable Introducer 12F | Freudenberg Medical, LLC | Oct 4, 2019 | SESE |
| K190167 | MitraClip G4 Steerable Guide Catheter | Abbott | May 29, 2019 | SESE |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | Nov 26, 2018 | SESE |
| K172394 | Steerable Guide Catheter | Abbott Vascular | Sep 6, 2017 | SESE |
| K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | Apr 6, 2017 | SESE |
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | Sep 20, 2016 | SESE |
| K161985 | Steerable Guide Catheter | Abbott Vascular | Aug 7, 2016 | SESE |
| K152310 | HeartLight Deflectable Sheath | Cardiofocus, Inc. | Feb 24, 2016 | SESE |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | Feb 1, 2016 | SESE |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | Hansen Medical, Inc. | Aug 18, 2015 | SESE |
| K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT | Hansen Medical | Feb 7, 2014 | SESE |
| K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | Medtronic Cryocath, LP | Dec 27, 2012 | SESE |
Top Applicants
- Catheter Research C/O Burditt, Bowles & Radzius — 4 clearances
- Evalve, Inc. — 4 clearances
- Medtronic Cryocath, LP — 4 clearances
- Abbott Vascular — 3 clearances
- Acutus Medical, Inc. — 3 clearances
