Cleared Traditional

MICROFRANCE(R) WORMALD VASCULAR CLAMP

K112662 · Medtronic Xomed, Inc. · Cardiovascular
Jan 2012
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K112662 is an FDA 510(k) clearance for the MICROFRANCE(R) WORMALD VASCULAR CLAMP, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on January 20, 2012, 129 days after receiving the submission on September 13, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K112662 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2011
Decision Date January 20, 2012
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXC — Clamp, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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