K102176 is an FDA 510(k) clearance for the FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10. This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Medtronic Cryocath, LP (Kirkland, CA). The FDA issued a Cleared decision on September 1, 2010, 29 days after receiving the submission on August 3, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K102176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2010 |
| Decision Date | September 01, 2010 |
| Days to Decision | 29 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 |