The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for Lemaitre Retrograde Valvulotome.
| Device ID | K924171 |
| 510k Number | K924171 |
| Device Name: | LEMAITRE RETROGRADE VALVULOTOME |
| Classification | Valvulotome |
| Applicant | VASCUTECH, INC. 140 HAVERHILL ST. Andover, MA 01810 |
| Contact | George W Lemaitre |
| Correspondent | George W Lemaitre VASCUTECH, INC. 140 HAVERHILL ST. Andover, MA 01810 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-18 |
| Decision Date | 1993-02-16 |