The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Angioscope W/the Optiscope-2 Integrated Angioscopy.
| Device ID | K895538 |
| 510k Number | K895538 |
| Device Name: | ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY |
| Classification | Angioscope |
| Applicant | TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
| Contact | Merritt M Girgis |
| Correspondent | Merritt M Girgis TRIMEDYNE, INC. 1311 VALENCIA AVE. Tustin, CA 92680 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-13 |
| Decision Date | 1990-04-26 |