Cleared Special

K182916 - Pruitt F3 Carotid Shunt

K182916 is the FDA 510(k) clearance for Pruitt F3 Carotid Shunt by Lemaitre Vascular. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Special 510(k) pathway after a 29-day FDA review.

K182916 · Lemaitre Vascular · Cardiovascular device
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Nov 2018
Decision
29d
Days
Class 2
Risk

K182916 is an FDA 510(k) clearance for the Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Caro.... Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Lemaitre Vascular (Burlington, US). The FDA issued a Cleared decision on November 16, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lemaitre Vascular devices

Submission Details

510(k) Number K182916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2018
Decision Date November 16, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K182916.
RenovoCath
K191606 · Renovorx, Inc. · Aug 2019
Eclipse 2L
K183045 · Balt USA, LLC · Apr 2019
Occlusion Balloon Catheter
K183679 · Qxmedical, LLC · Apr 2019
Sniper Infusion Catheter with Balloon Occlusion
K180904 · Embolx, Inc. · Jun 2018
GORE Molding and Occlusion Balloon Catheter
K172567 · W. L. Gore and Associates, Inc. · Jan 2018
REBOA Balloon Catheter
K160598 · NuMED, Inc. · Jun 2016