The following data is part of a premarket notification filed by The Heart Valve Div. Medtronic Cardiovascular Surg with the FDA for Posterior Annuloplasty Band (model 607).
| Device ID | K960356 |
| 510k Number | K960356 |
| Device Name: | POSTERIOR ANNULOPLASTY BAND (MODEL 607) |
| Classification | Ring, Annuloplasty |
| Applicant | THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG 18011 SOUTH MITCHELL Irvine, CA 92714 |
| Contact | Kathleen T Boehm |
| Correspondent | Kathleen T Boehm THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG 18011 SOUTH MITCHELL Irvine, CA 92714 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-25 |
| Decision Date | 1996-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994759177 | K960356 | 000 |
| 10681490268551 | K960356 | 000 |