The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Cosgrove Edwards Annuloplasty System, Model 4600.
| Device ID | K923367 |
| 510k Number | K923367 |
| Device Name: | COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 |
| Classification | Ring, Annuloplasty |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Roberta Hines |
| Correspondent | Roberta Hines BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-09 |
| Decision Date | 1993-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103020571 | K923367 | 000 |
| 00690103020564 | K923367 | 000 |
| 00690103020557 | K923367 | 000 |
| 00690103020540 | K923367 | 000 |
| 00690103020533 | K923367 | 000 |
| 00690103020526 | K923367 | 000 |
| 00690103020519 | K923367 | 000 |