The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Carpentier-edwards Flex. Annuloplasty.
| Device ID | K792441 |
| 510k Number | K792441 |
| Device Name: | CARPENTIER-EDWARDS FLEX. ANNULOPLASTY |
| Classification | Ring, Annuloplasty |
| Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Se Subject To Traking & Pms (PT) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-29 |
| Decision Date | 1980-03-17 |