The following data is part of a premarket notification filed by Baxter Edwards with the FDA for 4.5f Imagecath(r) Coronary Angioscope, Cov45.
| Device ID | K926433 |
| 510k Number | K926433 |
| Device Name: | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 |
| Classification | Angioscope |
| Applicant | BAXTER EDWARDS 1402 ALTON AVE. Irvine, CA 92714 |
| Contact | Lawrence Stevens |
| Correspondent | Lawrence Stevens BAXTER EDWARDS 1402 ALTON AVE. Irvine, CA 92714 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-23 |
| Decision Date | 1993-03-23 |