Cleared Traditional

K130215 - GORE ACUSEAL VASCULAR GRAFT

K130215 is an FDA 510(k) clearance for GORE ACUSEAL VASCULAR GRAFT, manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K130215

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.

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. 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 155
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K130215.
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
K142062 · Vascular Flow Technologies, Ltd. · Nov 2014
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
K141124 · Vascular Flow Technologies, Ltd. · May 2014
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
K131778 · Maquet Cardiovascular, LLC · Nov 2013
FLIXENE IFG VASCULAR GRAFT
K130142 · Atrium Medical Corporation · Mar 2013
HERO GRAFT
K124039 · Hemoshpere, Inc., A Cryolife Company · Mar 2013
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · LeMaitre Vascular, Inc. · Feb 2013