The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Lemaitre Valvulotome Ii.
| Device ID | K946352 |
| 510k Number | K946352 |
| Device Name: | LEMAITRE VALVULOTOME II |
| Classification | Valvulotome |
| Applicant | VASCUTECH, INC. 790 TURNPIKE ST. North Andover, MA 01845 |
| Contact | George W Lemaitre |
| Correspondent | George W Lemaitre VASCUTECH, INC. 790 TURNPIKE ST. North Andover, MA 01845 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-30 |
| Decision Date | 1995-06-21 |