The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Medtronic Contour 3d Annuloplasty Ring, Model 690r.
| Device ID | K101212 |
| 510k Number | K101212 |
| Device Name: | MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R |
| Classification | Ring, Annuloplasty |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Becky Hannack |
| Correspondent | Becky Hannack MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-30 |
| Decision Date | 2010-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994845375 | K101212 | 000 |
| 00643169121683 | K101212 | 000 |
| 00643169121690 | K101212 | 000 |
| 00643169121706 | K101212 | 000 |
| 00643169121713 | K101212 | 000 |
| 00643169121720 | K101212 | 000 |
| 00613994845320 | K101212 | 000 |
| 00613994845337 | K101212 | 000 |
| 00613994845344 | K101212 | 000 |
| 00613994845351 | K101212 | 000 |
| 00613994845368 | K101212 | 000 |
| 00643169121676 | K101212 | 000 |