The following data is part of a premarket notification filed by Medtronic Heart Valves with the FDA for Simplici-t Annuloplasty System.
| Device ID | K052970 |
| 510k Number | K052970 |
| Device Name: | SIMPLICI-T ANNULOPLASTY SYSTEM |
| Classification | Ring, Annuloplasty |
| Applicant | MEDTRONIC HEART VALVES 8299 CENTRAL AVE., N.E. Spring Lake Park, MN 55432 -3576 |
| Contact | Phil Neururer |
| Correspondent | Phil Neururer MEDTRONIC HEART VALVES 8299 CENTRAL AVE., N.E. Spring Lake Park, MN 55432 -3576 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-24 |
| Decision Date | 2006-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994759276 | K052970 | 000 |
| 00763000411367 | K052970 | 000 |