K093903 is an FDA 510(k) clearance for the ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Genesee Biomedical, Inc. (Denver, US). The FDA issued a Cleared decision on July 15, 2010, 205 days after receiving the submission on December 22, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K093903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2009 |
| Decision Date | July 15, 2010 |
| Days to Decision | 205 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRH - Ring, Annuloplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3800 |