The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Baxter Handle Model 1150.
| Device ID | K944214 |
| 510k Number | K944214 |
| Device Name: | BAXTER HANDLE MODEL 1150 |
| Classification | Holder, Heart-valve, Prosthesis |
| Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Contact | Easter Saltz |
| Correspondent | Easter Saltz BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Product Code | DTJ |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1995-02-10 |