DRA — Catheter, Steerable Class II
FDA Device Classification
Classification Details
- Product Code
- DRA
- Device Class
- Class II
- Regulation Number
- 870.1280
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250529 | kardium | Globe Introducer (601-01001) | June 3, 2025 |
| K233248 | boston scientific corporation | FARADRIVE Steerable Sheath | December 11, 2023 |
| K232321 | medtronic | FlexCath Contour Steerable Sheath | October 31, 2023 |
| K223824 | boston scientific corporation | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping | March 22, 2023 |
| K221397 | abbott medical | MitraClip G4 Steerable Guide Catheter | September 28, 2022 |
| K221044 | acutus medical | AcQGuide® VUE Steerable Sheath | May 5, 2022 |
| K211100 | acutus medical | AcQGuide MAX Steerable Sheath | May 14, 2021 |
| K202620 | medtronic cryocath | FlexCath Advance Steerable Sheath and Dilator | November 13, 2020 |
| K192422 | freudenberg medical | Steerable Introducer 12F | October 4, 2019 |
| K190167 | abbott | MitraClip G4 Steerable Guide Catheter | May 29, 2019 |
| K183174 | medtronic cryocath | FlexCath Advance Steerable Sheath and Dilator | November 26, 2018 |
| K172394 | abbott vascular | Steerable Guide Catheter | September 6, 2017 |
| K162925 | acutus medical | AcQGuide Steerable Sheath | April 6, 2017 |
| K160919 | hansen medical | Hansen Medical Magellan Robotic Catheter 9Fr | September 20, 2016 |
| K161985 | abbott vascular | Steerable Guide Catheter | August 7, 2016 |
| K152310 | cardiofocus | HeartLight Deflectable Sheath | February 24, 2016 |
| K153304 | hansen medical | Hansen Medical Magellan Robotic Catheter eKit | February 1, 2016 |
| K151463 | hansen medical | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components | August 18, 2015 |
| K133552 | hansen medical | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR | February 7, 2014 |
| K123591 | medtronic cryocath | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | December 27, 2012 |