Cleared Special

K130016 - LIFESPAN EPTFE VASCULAR GRAFT

K130016 is the FDA 510(k) clearance for LIFESPAN EPTFE VASCULAR GRAFT by LeMaitre Vascular, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Special 510(k) pathway after a 35-day FDA review.

K130016 · LeMaitre Vascular, Inc. · Cardiovascular device
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Feb 2013
Decision
35d
Days
Class 2
Risk

K130016 is an FDA 510(k) clearance for the LIFESPAN EPTFE VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on February 5, 2013 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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, Inc. devices

Submission Details

510(k) Number K130016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 01, 2013
Decision Date February 05, 2013
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 96
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K130016.
exGraft, exGraft Carbon ePTFE Vascular Grafts
K180957 · Peca Labs · Aug 2018
HeRO Graft
K172637 · Merit Medical Systems, Inc. · Nov 2017
GORE ACUSEAL VASCULAR GRAFT
K130215 · W.L. Gore & Associates, Inc. · Apr 2013
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · Atrium Medical Corp. · Aug 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
K113101 · Boston Scientific Corporation · Jan 2012
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
K102596 · Atrium Medical Corp. · Oct 2010