The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Carpentier-edwards Physio Annuloplasty Ring.
| Device ID | K926138 |
| 510k Number | K926138 |
| Device Name: | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING |
| 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 | 1992-12-07 |
| Decision Date | 1993-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103020298 | K926138 | 000 |
| 00690103020281 | K926138 | 000 |
| 00690103020274 | K926138 | 000 |
| 00690103020267 | K926138 | 000 |
| 00690103020250 | K926138 | 000 |
| 00690103020243 | K926138 | 000 |
| 00690103020236 | K926138 | 000 |
| 00690103020229 | K926138 | 000 |
| 00690103020212 | K926138 | 000 |