K202620 is an FDA 510(k) clearance for the FlexCath Advance Steerable Sheath and Dilator. This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Medtronic Cryocath, LP (Minneapolis, US). The FDA issued a Cleared decision on November 13, 2020, 64 days after receiving the submission on September 10, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K202620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2020 |
| Decision Date | November 13, 2020 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRA - Catheter, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1280 |