The following data is part of a premarket notification filed by Endovascular, Inc. with the FDA for Disposable Steerable Angioscope.
| Device ID | K931421 |
| 510k Number | K931421 |
| Device Name: | DISPOSABLE STEERABLE ANGIOSCOPE |
| Classification | Angioscope |
| Applicant | ENDOVASCULAR, INC. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas ENDOVASCULAR, INC. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
| Product Code | LYK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-22 |
| Decision Date | 1993-06-16 |