The following data is part of a premarket notification filed by Sorin Group Italia S.r.l with the FDA for Memo 3d Rechord.
| Device ID | K142221 |
| 510k Number | K142221 |
| Device Name: | MEMO 3D ReChord |
| Classification | Ring, Annuloplasty |
| Applicant | SORIN GROUP ITALIA S.R.L VIA CRESCENTINO SN Saluggia, IT 13040 |
| Contact | Mauro Ercolani |
| Correspondent | Fabio De Pasquale SORIN GROUP CANADA, INC 5005 NORTH FRASER WAY Burnaby, CA V5j 5m1 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-12 |
| Decision Date | 2014-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08022057015129 | K142221 | 000 |
| 08022057015112 | K142221 | 000 |
| 08022057015105 | K142221 | 000 |
| 08022057015099 | K142221 | 000 |
| 08022057015082 | K142221 | 000 |
| 08022057015075 | K142221 | 000 |
| 08022057015068 | K142221 | 000 |
| 08022057015051 | K142221 | 000 |