Submission Details
| 510(k) Number | K180411 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
MEMO 4D
Mar 2018
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K180411 is an FDA 510(k) clearance for the MEMO 4D, 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 review panel. Regulated under 21 CFR 870.3800.
Device Classification
| Product Code | KRH — Ring, Annuloplasty |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3800 |
Manufacturer
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