K142221 is an FDA 510(k) clearance for the MEMO 3D ReChord. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Sorin Group Italia S.R.L. (Saluggia Vercelli, IT). The FDA issued a Cleared decision on August 29, 2014, 17 days after receiving the submission on August 12, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K142221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2014 |
| Decision Date | August 29, 2014 |
| Days to Decision | 17 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 |