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 |