Cleared Special

Antegrade LeMills Valvulotome

K142660 · LeMaitre Vascular, Inc. · Cardiovascular
Oct 2014
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K142660 is an FDA 510(k) clearance for the Antegrade 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 October 17, 2014, 29 days after receiving the submission on September 18, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K142660 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2014
Decision Date October 17, 2014
Days to Decision 29 days
Submission Type Special
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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