Cleared Traditional

K190267 - EZE SIT Valvulotome

K190267 is an FDA 510(k) clearance for EZE SIT Valvulotome, manufactured by Lemaitre Vascular. The device is a Class 2 Cardiovascular device with product code MGZ cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K190267 · Lemaitre Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
264d
Days
Class 2
Risk

K190267 is an FDA 510(k) clearance for the EZE SIT Valvulotome. Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by Lemaitre Vascular (Burlington, US). The FDA issued a Cleared decision on October 30, 2019 after a review of 264 days - an extended review 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: 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 devices

FDA 510(k) Submission Details - K190267

510(k) Number K190267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 125d · This submission: 264d
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 K190267.
LimFlow Vector
K260188 · LimFlow, Inc. · Mar 2026
Boomerang Valvulotome (BMGVT080)
K250105 · Aveera Medical, Inc. · Jul 2025
LimFlow Vector
K221902 · LimFlow, Inc. · Dec 2022
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