Cleared Traditional

1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME

K140042 · LeMaitre Vascular, Inc. · Cardiovascular
Apr 2014
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K140042 is an FDA 510(k) clearance for the 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME, a Valvulotome (Class II — Special Controls, product code MGZ), submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on April 10, 2014, 92 days after receiving the submission on January 8, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K140042 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2014
Decision Date April 10, 2014
Days to Decision 92 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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