Cleared Special

K071367 - FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05

K071367 is an FDA 510(k) clearance for FLEXCEL CAROTID SHUNT (INLYING), manufactured by LeMaitre Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Special 510(k) pathway after a 105-day FDA review.

K071367 · LeMaitre Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071367

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

MJN Device Classification - Class 2, Special Controls

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.
DUOFLO CATHETER
K080700 · Thermopeutix, Inc. · Sep 2008
MICRUS ASCENT OCCLUSION BALLOON CATHETER
K080861 · Micrus Endovascular Corporation · Aug 2008
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
K081454 · Possis Medical, Inc. · Jun 2008
GORE BALLOON SHEATH
K070770 · W.L. Gore & Associates, Inc. · Jun 2007
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
K062220 · Possis Medical, Inc. · Aug 2006
KAVS - CATHETER, MODELS 1107100 & 1107060
K052844 · Richter & Rothe AG · Mar 2006
K071367 · FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
Download PDF FDA Summary LeMaitre Vascular, In…