Cleared Traditional

K140042 - 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME

K140042 is an FDA 510(k) clearance for 1.5MM HYDRO 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 92-day FDA review.

K140042 · LeMaitre Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
92d
Days
Class 2
Risk

K140042 is an FDA 510(k) clearance for the 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME. Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on April 10, 2014 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all LeMaitre Vascular, Inc. devices

FDA 510(k) Submission Details - K140042

510(k) Number K140042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 K140042.
LimFlow Vector
K221902 · LimFlow, Inc. · Dec 2022
EZE SIT Valvulotome
K190267 · Lemaitre Vascular · Oct 2019
Antegrade LeMills Valvulotome
K142660 · LeMaitre Vascular, Inc. · Oct 2014
LEMILLS VALVULOTOME
K132047 · LeMaitre Vascular, Inc. · Nov 2013
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
K132190 · LeMaitre Vascular, Inc. · Aug 2013
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
K111884 · LeMaitre Vascular, Inc. · Jul 2011