K180411 is an FDA 510(k) clearance for the MEMO 4D. This device is classified as a Ring, Annuloplasty (Class II - Special Controls, product code KRH).
Submitted by Sorin Group Italia S.R.L. (Saluggia, IT). The FDA issued a Cleared decision on March 16, 2018, 29 days after receiving the submission on February 15, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.
| 510(k) Number | K180411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2018 |
| Decision Date | March 16, 2018 |
| Days to Decision | 29 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 |