Cleared Traditional

LEMILLS VALVULOTOME

K132047 · LeMaitre Vascular, Inc. · Cardiovascular
Nov 2013
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K132047 is an FDA 510(k) clearance for the LEMILLS VALVULOTOME, a Valvulotome (Class II — Special Controls, product code MGZ), submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on November 5, 2013, 126 days after receiving the submission on July 2, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K132047 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2013
Decision Date November 05, 2013
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MGZ — Valvulotome
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885

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