Cleared Traditional

Pruitt F3-S Carotid Shunt

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

About This 510(k) Submission

K143454 is an FDA 510(k) clearance for the Pruitt F3-S Carotid Shunt, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on August 27, 2015, 267 days after receiving the submission on December 3, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K143454 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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