K202253 is an FDA 510(k) clearance for the TruForm Sievers Annuloplasty Ring. 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 6, 2020, 57 days after receiving the submission on August 10, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K202253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2020 |
| Decision Date | October 06, 2020 |
| Days to Decision | 57 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 |