The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Annuloplasty Rings, Model 4400 Mirtal And 4500 Tri.
| Device ID | K912554 |
| 510k Number | K912554 |
| Device Name: | ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI |
| 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 | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-11 |
| Decision Date | 1991-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103020441 | K912554 | 000 |
| 00690103020069 | K912554 | 000 |
| 00690103020076 | K912554 | 000 |
| 00690103020083 | K912554 | 000 |
| 00690103020090 | K912554 | 000 |
| 00690103020106 | K912554 | 000 |
| 00690103020113 | K912554 | 000 |
| 00690103020120 | K912554 | 000 |
| 00690103020397 | K912554 | 000 |
| 00690103020403 | K912554 | 000 |
| 00690103020410 | K912554 | 000 |
| 00690103020427 | K912554 | 000 |
| 00690103020434 | K912554 | 000 |
| 00690103020052 | K912554 | 000 |