Cleared Traditional

Pruitt F3-S Polyurethane Carotid Shunt

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

About This 510(k) Submission

K152833 is an FDA 510(k) clearance for the Pruitt F3-S Polyurethane 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 January 21, 2016, 114 days after receiving the submission on September 29, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K152833 FDA.gov
FDA Decision Cleared 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

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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