K101212 is an FDA 510(k) clearance for the MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on August 7, 2010, 99 days after receiving the submission on April 30, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K101212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2010 |
| Decision Date | August 07, 2010 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRH — Ring, Annuloplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3800 |