K103520 is an FDA 510(k) clearance for the CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on June 24, 2011, 206 days after receiving the submission on November 30, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K103520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2010 |
| Decision Date | June 24, 2011 |
| Days to Decision | 206 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 |