Cleared Special

K071367 - FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K071367 · LeMaitre Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
105d
Days
Class 2
Risk

K071367 is an FDA 510(k) clearance for the FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on August 29, 2007 after a review of 105 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. 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. Standard predicate reliance. 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, Inc. devices

Submission Details

510(k) Number K071367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2007
Decision Date August 29, 2007
Days to Decision 105 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K071367.
pREBOA-PRO Catheter
K243795 · Prytime Medical Devices, Inc. · Sep 2025
Bridge Plus Occlusion Balloon (590-002)
K251358 · Philips Image Guided Therapy Devices · Jun 2025
preCARDIA Occlusion System
K221294 · Abiomed, Inc. · Jun 2023
Fogarty Occlusion Catheter
K211610 · Edwards Lifesciences, LLC · Feb 2022