Cleared Traditional

K130215 - GORE ACUSEAL VASCULAR GRAFT

K130215 is the FDA 510(k) clearance for GORE ACUSEAL VASCULAR GRAFT by W.L. Gore & Associates, Inc.. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K130215 · W.L. Gore & Associates, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
70d
Days
Class 2
Risk

K130215 is an FDA 510(k) clearance for the GORE ACUSEAL VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on April 9, 2013 after a review of 70 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K130215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2013
Decision Date April 09, 2013
Days to Decision 70 days
Submission Type Traditional
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
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01173718 Completed Interventional Industry-sponsored

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)

138
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied End Stage Renal Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Marc Glickman, MD
Sponsor W.L.Gore & Associates (industry)
Started 2010-07-01 → Primary completion 2012-09-01 → Completed 2013-02-01
Primary outcome
Cumulative Patency at 6 Months
Secondary outcome
Primary Unassisted Patency at 6 Months
View full study on ClinicalTrials.gov

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 K130215.
exGraft, exGraft Carbon
K183613 · Peca Labs · Apr 2019
exGraft, exGraft Carbon ePTFE Vascular Grafts
K180957 · Peca Labs · Aug 2018
HeRO Graft
K172637 · Merit Medical Systems, Inc. · Nov 2017
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · LeMaitre Vascular, Inc. · Feb 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