510(k) K891296

ATRAUMAX(TM) SURGICAL CLAMPS by Applied Vascular Devices, Inc. — Product Code DXC

K891296 is an FDA 510(k) premarket notification submitted by Applied Vascular Devices, Inc. for the device "ATRAUMAX(TM) SURGICAL CLAMPS". The FDA issued a decision of Substantially Equivalent on June 7, 1989. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Applied Vascular Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1989
Date Received
March 13, 1989
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