The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Angioscope.
| Device ID | K830084 |
| 510k Number | K830084 |
| Device Name: | ANGIOSCOPE |
| Classification | Angioscope |
| Applicant | TRIMEDYNE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-11 |
| Decision Date | 1983-06-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ANGIOSCOPE 73424457 not registered Dead/Abandoned |
TRIMEDYNE, INC. 1983-05-04 |