The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Medtronic Profile 3d Annuloplasty Ring, Model 680r.
| Device ID | K073324 |
| 510k Number | K073324 |
| Device Name: | MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R |
| Classification | Ring, Annuloplasty |
| Applicant | MEDTRONIC INC. 8299 CENTRAL AVENUE NE Minneapolis, MN 55432 |
| Contact | Becky Hannack |
| Correspondent | Becky Hannack MEDTRONIC INC. 8299 CENTRAL AVENUE NE Minneapolis, MN 55432 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-27 |
| Decision Date | 2008-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994759269 | K073324 | 000 |
| 00613994749406 | K073324 | 000 |
| 00613994749390 | K073324 | 000 |
| 00613994749383 | K073324 | 000 |
| 00613994749376 | K073324 | 000 |
| 00613994410344 | K073324 | 000 |
| 00613994410337 | K073324 | 000 |
| 00613994410313 | K073324 | 000 |
| 00613994410306 | K073324 | 000 |
| 00613994749413 | K073324 | 000 |
| 00613994749420 | K073324 | 000 |
| 00613994749437 | K073324 | 000 |
| 00613994759252 | K073324 | 000 |
| 00613994759245 | K073324 | 000 |
| 00613994759238 | K073324 | 000 |
| 00613994759221 | K073324 | 000 |
| 00613994759214 | K073324 | 000 |
| 00613994759207 | K073324 | 000 |
| 00613994759191 | K073324 | 000 |
| 00613994759184 | K073324 | 000 |
| 00613994410283 | K073324 | 000 |