K183174 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 26, 2018, 10 days after receiving the submission on November 16, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K183174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2018 |
| Decision Date | November 26, 2018 |
| Days to Decision | 10 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 |