K083623 is an FDA 510(k) clearance for the CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100. 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 April 15, 2009, 128 days after receiving the submission on December 8, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K083623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2008 |
| Decision Date | April 15, 2009 |
| Days to Decision | 128 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 |