Cleared Traditional

K132022 - LEMAITRE 8F OCCLUSION CATHETER

K132022 is the FDA 510(k) clearance for LEMAITRE 8F OCCLUSION CATHETER by LeMaitre Vascular, Inc.. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K132022 · LeMaitre Vascular, Inc. · Cardiovascular device
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Nov 2013
Decision
128d
Days
Class 2
Risk

K132022 is an FDA 510(k) clearance for the LEMAITRE 8F OCCLUSION CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on November 6, 2013 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 K132022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date November 06, 2013
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 47
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K132022.
REBOA Balloon Catheter
K160598 · NuMED, Inc. · Jun 2016
Fogarty Occlusion Catheter
K152762 · Edwards Lifesciences, LLC · Nov 2015
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · Boston Scientific Corp · Jul 2014
OCCLUSION BALLOON CATHETER
K132990 · Boston Scientific Corp · Oct 2013
PTS-X SIZING BALLOON CATHETER
K131869 · NuMED, Inc. · Aug 2013
TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
K122576 · Stryker Neurovascular · Jan 2013