The following data is part of a premarket notification filed by Baxter Edwards with the FDA for 4.5f Imagecath Coronary Angioscope, Model Cov45 [subsequently Referred To As The Modified Angioscope[.
| Device ID | K952638 |
| 510k Number | K952638 |
| Device Name: | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ |
| Classification | Angioscope |
| Applicant | BAXTER EDWARDS 17221 RED HILL AVE. PO BOX 11150 Santa Ana, CA 92711 -1150 |
| Contact | Ric Ruedy |
| Correspondent | Ric Ruedy BAXTER EDWARDS 17221 RED HILL AVE. PO BOX 11150 Santa Ana, CA 92711 -1150 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-09 |
| Decision Date | 1995-07-28 |