K912554 is an FDA 510(k) clearance for the ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI. 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 September 9, 1991, 90 days after receiving the submission on June 11, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K912554 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1991 |
| Decision Date | September 09, 1991 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | KRH — Ring, Annuloplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3800 |