510(k) K072167

COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE by Advanced Vascular Dynamics — Product Code DXC

K072167 is an FDA 510(k) premarket notification submitted by Advanced Vascular Dynamics for the device "COMFORTPRESS VASCULAR COMPRESSION ASSIST DEVICE". The FDA issued a decision of Substantially Equivalent on September 6, 2007. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Advanced Vascular Dynamics has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2007
Date Received
August 6, 2007
Clearance Type
Special
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