The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Carpenter-edwards Classic Ring With Duraflo Treatment Models 4425 (mitral) And 4525 (tricuspid), Carpenter-edwards Physm.
| Device ID | K980487 |
| 510k Number | K980487 |
| Device Name: | CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM |
| Classification | Ring, Annuloplasty |
| Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Contact | Larry Wood |
| Correspondent | Larry Wood BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-09 |
| Decision Date | 1998-07-07 |
| Summary: | summary |