Cleared Traditional

K143454 - Pruitt F3-S Carotid Shunt (FDA 510(k) Clearance)

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

K143454 · LeMaitre Vascular, Inc. · Cardiovascular device
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Aug 2015
Decision
267d
Days
Class 2
Risk

K143454 is an FDA 510(k) clearance for the Pruitt F3-S 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 August 27, 2015 after a review of 267 days - an extended review cycle.

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 K143454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2014
Decision Date August 27, 2015
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
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 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K143454.
pREBOA-PRO Catheter
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Bridge Plus Occlusion Balloon (590-002)
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preCARDIA Occlusion System
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Fogarty Occlusion Catheter
K211610 · Edwards Lifesciences, LLC · Feb 2022