The following data is part of a premarket notification filed by Medtronic Heart Valves with the FDA for Cg Future Annuloplasty Band.
| Device ID | K052860 |
| 510k Number | K052860 |
| Device Name: | CG FUTURE ANNULOPLASTY BAND |
| Classification | Ring, Annuloplasty |
| Applicant | MEDTRONIC HEART VALVES 8299 CENTRAL AVE., N.E. M.S. P108 Minneapolis, MN 55432 -3576 |
| Contact | Julie Sherman |
| Correspondent | Julie Sherman MEDTRONIC HEART VALVES 8299 CENTRAL AVE., N.E. M.S. P108 Minneapolis, 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 | 2005-10-11 |
| Decision Date | 2005-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994758873 | K052860 | 000 |
| 00613994521132 | K052860 | 000 |
| 00613994521125 | K052860 | 000 |
| 00613994521118 | K052860 | 000 |
| 00613994521101 | K052860 | 000 |
| 00613994521095 | K052860 | 000 |
| 00613994521088 | K052860 | 000 |
| 00643169793644 | K052860 | 000 |
| 00643169793637 | K052860 | 000 |
| 00643169793620 | K052860 | 000 |
| 00643169793613 | K052860 | 000 |
| 00643169793606 | K052860 | 000 |
| 00643169793590 | K052860 | 000 |
| 00613994521149 | K052860 | 000 |
| 00613994751751 | K052860 | 000 |
| 00613994758859 | K052860 | 000 |
| 00613994758835 | K052860 | 000 |
| 00613994758811 | K052860 | 000 |
| 00613994758798 | K052860 | 000 |
| 00613994758774 | K052860 | 000 |
| 00613994758750 | K052860 | 000 |
| 00613994751812 | K052860 | 000 |
| 00613994751805 | K052860 | 000 |
| 00613994751799 | K052860 | 000 |
| 00613994751782 | K052860 | 000 |
| 00613994751775 | K052860 | 000 |
| 00613994751768 | K052860 | 000 |
| 00643169793583 | K052860 | 000 |