The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Sjm Seguin Annuloplasty Ring (seguin Ring), Model Sarp-(size).
| Device ID | K014037 |
| 510k Number | K014037 |
| Device Name: | SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(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 | 2001-12-07 |
| Decision Date | 2002-01-04 |
| Summary: | summary |