Cleared Special

K130016 - LIFESPAN EPTFE VASCULAR GRAFT

K130016 is an FDA 510(k) clearance for LIFESPAN EPTFE VASCULAR GRAFT, manufactured by LeMaitre Vascular, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K130016

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

DSY Device Classification - Class 2, Special Controls

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 153
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K130016.
GORE ACUSEAL VASCULAR GRAFT
K130215 · W.L. Gore & Associates, Inc. · Apr 2013
FLIXENE IFG VASCULAR GRAFT
K130142 · Atrium Medical Corporation · Mar 2013
HERO GRAFT
K124039 · Hemoshpere, Inc., A Cryolife Company · Mar 2013
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · Atrium Medical Corp. · Aug 2012
HERO GRAFT
K121532 · Hemosphere, Inc. · Jun 2012
HERO GRAFT
K120006 · Hemosphere, Inc. · Feb 2012