Cleared Traditional

EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME

K132190 · LeMaitre Vascular, Inc. · Cardiovascular

Aug 2013

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K132190 is an FDA 510(k) clearance for the EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME, a Valvulotome (Class II — Special Controls, product code MGZ), submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on August 5, 2013, 21 days after receiving the submission on July 15, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number	K132190 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2013
Decision Date	August 05, 2013
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF