Cleared Traditional

MOLLRING MULTITASC

K121415 · LeMaitre Vascular, Inc. · Cardiovascular
Sep 2012
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K121415 is an FDA 510(k) clearance for the MOLLRING MULTITASC, a Stripper, Artery, Intraluminal (Class II — Special Controls, product code DWX), submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on September 5, 2012, 117 days after receiving the submission on May 11, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4875.

Submission Details

510(k) Number K121415 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2012
Decision Date September 05, 2012
Days to Decision 117 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWX — Stripper, Artery, Intraluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4875

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