The following data is part of a premarket notification filed by Vascular Control Systems, Inc with the FDA for Vcs-a Series Clamp.
Device ID | K011863 |
510k Number | K011863 |
Device Name: | VCS-A SERIES CLAMP |
Classification | Clamp, Vascular |
Applicant | VASCULAR CONTROL SYSTEMS, INC 32236- E PASEO ADELANTO San Juan Capistrano, CA 92675 |
Contact | Al Memmolo |
Correspondent | Al Memmolo VASCULAR CONTROL SYSTEMS, INC 32236- E PASEO ADELANTO San Juan Capistrano, CA 92675 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-14 |
Decision Date | 2002-02-15 |
Summary: | summary |