K161815 is an FDA 510(k) clearance for the FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band. 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 October 12, 2016, 103 days after receiving the submission on July 1, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K161815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2016 |
| Decision Date | October 12, 2016 |
| Days to Decision | 103 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 |