The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Sjm Rigid Saddle Ring Model Rsar-(size).
| Device ID | K042734 |
| 510k Number | K042734 |
| Device Name: | SJM RIGID SADDLE RING MODEL RSAR-(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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-01 |
| Decision Date | 2004-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734009461 | K042734 | 000 |
| 05415067044655 | K042734 | 000 |
| 05415067044716 | K042734 | 000 |
| 05415067044730 | K042734 | 000 |
| 05414734009416 | K042734 | 000 |
| 05414734009423 | K042734 | 000 |
| 05414734009430 | K042734 | 000 |
| 05414734009447 | K042734 | 000 |
| 05414734009454 | K042734 | 000 |
| 05415067044693 | K042734 | 000 |