The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Sjm Tailor Annuloplasty Ring Model Tarp- (size).
| Device ID | K014161 |
| 510k Number | K014161 |
| Device Name: | SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE) |
| Classification | Ring, Annuloplasty |
| Applicant | ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul, MN 55117 |
| Contact | William Mckelvey |
| Correspondent | William Mckelvey ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul, MN 55117 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-19 |
| Decision Date | 2002-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734007726 | K014161 | 000 |
| 05414734007719 | K014161 | 000 |
| 05414734007702 | K014161 | 000 |
| 05414734007696 | K014161 | 000 |
| 05414734007689 | K014161 | 000 |
| 05414734007672 | K014161 | 000 |
| 05415067044495 | K014161 | 000 |
| 05415067044457 | K014161 | 000 |
| 05415067044396 | K014161 | 000 |