Cleared Traditional

EZE SIT Valvulotome

K190267 · Lemaitre Vascular · Cardiovascular
Oct 2019
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K190267 is an FDA 510(k) clearance for the EZE SIT Valvulotome, a Valvulotome (Class II — Special Controls, product code MGZ), submitted by Lemaitre Vascular (Burlington, US). The FDA issued a Cleared decision on October 30, 2019, 264 days after receiving the submission on February 8, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K190267 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2019
Decision Date October 30, 2019
Days to Decision 264 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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