Cleared Traditional

K132190 - EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME

K132190 is an FDA 510(k) clearance for EXPANDABLE LEMAITRE VALVULOTOME, manufactured by LeMaitre Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code MGZ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K132190 · LeMaitre Vascular, Inc. · Cardiovascular device
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Aug 2013
Decision
21d
Days
Class 2
Risk

K132190 is an FDA 510(k) clearance for the EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME. Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on August 5, 2013 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4885 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all LeMaitre Vascular, Inc. devices

FDA 510(k) Submission Details - K132190

510(k) Number K132190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MGZ Device Classification - Class 2, Special Controls

Product Code MGZ Valvulotome
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4885
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MGZ Valvulotome

All 16
Devices cleared under the same product code (MGZ) and FDA review panel - the closest regulatory comparables to K132190.
Antegrade LeMills Valvulotome
K142660 · LeMaitre Vascular, Inc. · Oct 2014
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
K140042 · LeMaitre Vascular, Inc. · Apr 2014
LEMILLS VALVULOTOME
K132047 · LeMaitre Vascular, Inc. · Nov 2013
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
K111884 · LeMaitre Vascular, Inc. · Jul 2011
VALVULOTOME BY KOVEN
K080178 · Koven Technology, Inc. · Jul 2008
FOGARTY VALVULOTOME, MODEL 700091
K001734 · Edwards Lifesciences, LLC · Mar 2001