K123591 is an FDA 510(k) clearance for the FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH). This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Medtronic Cryocath, LP (Mounds View, US). The FDA issued a Cleared decision on December 27, 2012, 36 days after receiving the submission on November 21, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K123591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2012 |
| Decision Date | December 27, 2012 |
| Days to Decision | 36 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRA - Catheter, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1280 |