510(k) K011863

VCS-A SERIES CLAMP by Vascular Control Systems, Inc. — Product Code DXC

K011863 is an FDA 510(k) premarket notification submitted by Vascular Control Systems, Inc. for the device "VCS-A SERIES CLAMP". The FDA issued a decision of Substantially Equivalent on February 15, 2002. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Vascular Control Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2002
Date Received
June 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type