510(k) K112662

MICROFRANCE(R) WORMALD VASCULAR CLAMP by Medtronic Xomed, Inc. — Product Code DXC

K112662 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "MICROFRANCE(R) WORMALD VASCULAR CLAMP". The FDA issued a decision of Substantially Equivalent on January 20, 2012. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2012
Date Received
September 13, 2011
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