K071281 is an FDA 510(k) clearance for the UNIRING - ANNULOPLASTY RING WITH SIZERS. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Peters Surgical (Bobigny, FR). The FDA issued a Cleared decision on August 3, 2007, 88 days after receiving the submission on May 7, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K071281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2007 |
| Decision Date | August 03, 2007 |
| Days to Decision | 88 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 |