The following data is part of a premarket notification filed by St. Jude Medical, Inc. with the FDA for Biflex(tm) Annuloplasty Ring.
| Device ID | K902159 |
| 510k Number | K902159 |
| Device Name: | BIFLEX(TM) ANNULOPLASTY RING |
| Classification | Ring, Annuloplasty |
| Applicant | ST. JUDE MEDICAL, INC. ONE LILLEHEI PLAZA St. Paul, MN 55117 |
| Contact | M Anderson |
| Correspondent | M Anderson 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 | 1990-05-15 |
| Decision Date | 1991-01-18 |