The following data is part of a premarket notification filed by Vascutech, Inc. with the FDA for The Samuels Retrograd Valvulotome.
Device ID | K932009 |
510k Number | K932009 |
Device Name: | THE SAMUELS RETROGRAD VALVULOTOME |
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 | 1993-04-23 |
Decision Date | 1993-09-21 |