K923367 is an FDA 510(k) clearance for the COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on January 6, 1993, 181 days after receiving the submission on July 9, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K923367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Product Development Protocol (SESP) |
| Date Received | July 09, 1992 |
| Decision Date | January 06, 1993 |
| Days to Decision | 181 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 |