Cleared Traditional

K152833 - Pruitt F3-S Polyurethane Carotid Shunt

K152833 is the FDA 510(k) clearance for Pruitt F3-S Polyurethane Carotid Shunt by LeMaitre Vascular, Inc.. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K152833 · LeMaitre Vascular, Inc. · Cardiovascular device
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Jan 2016
Decision
114d
Days
Class 2
Risk

K152833 is an FDA 510(k) clearance for the Pruitt F3-S Polyurethane Carotid Shunt. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on January 21, 2016 after a review of 114 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 K152833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date January 21, 2016
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
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 K152833.
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REBOA Balloon Catheter
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Fogarty Occlusion Catheter
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EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · Boston Scientific Corp · Jul 2014
OCCLUSION BALLOON CATHETER
K132990 · Boston Scientific Corp · Oct 2013