510(k) K023154

VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02 by Vascular Control Systems, Inc. — Product Code DXC

K023154 is an FDA 510(k) premarket notification submitted by Vascular Control Systems, Inc. for the device "VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02". The FDA issued a decision of Substantially Equivalent on December 20, 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
December 20, 2002
Date Received
September 23, 2002
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