The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Lemaitre Retrograde Valvulotome-manu-surgica Instr.
| Device ID | K850394 |
| 510k Number | K850394 |
| Device Name: | LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | VASCUTECH, INC. 1120 VERMONT AVENUE NW SUITE 1000 Washington, DC 20005 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli VASCUTECH, INC. 1120 VERMONT AVENUE NW SUITE 1000 Washington, DC 20005 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-04-24 |