510(k) K092503

RADAR VASCULAR COMPRESSION DEVICES by Advanced Vascular Dynamics — Product Code DXC

K092503 is an FDA 510(k) premarket notification submitted by Advanced Vascular Dynamics for the device "RADAR VASCULAR COMPRESSION DEVICES". The FDA issued a decision of Substantially Equivalent on November 19, 2009. 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
November 19, 2009
Date Received
August 14, 2009
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