DRA — Catheter, Steerable Class II
FDA product code DRA covers "Catheter, Steerable", a Class II medical device regulated under 21 CFR 870.1280. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |