Cleared Traditional

K140042 - 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140042 · LeMaitre Vascular, Inc. · Cardiovascular device
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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

Submission Details

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
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.

Device Classification

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.