The following data is part of a premarket notification filed by Endovascular, Inc. with the FDA for Disposable Optical Valvulotome.
| Device ID | K924075 |
| 510k Number | K924075 |
| Device Name: | DISPOSABLE OPTICAL VALVULOTOME |
| Classification | Valvulotome |
| 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 | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-12 |
| Decision Date | 1993-02-08 |