Cleared Traditional

K131778 - FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT

K131778 is an FDA 510(k) clearance for FUSION VASCULAR GRAFT AND FUSION BIOLIN..., manufactured by Maquet Cardiovascular, LLC. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K131778 · Maquet Cardiovascular, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Nov 2013
Decision
150d
Days
Class 2
Risk

K131778 is an FDA 510(k) clearance for the FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Maquet Cardiovascular, LLC (Wayne, US). The FDA issued a Cleared decision on November 14, 2013 after a review of 150 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Maquet Cardiovascular, LLC devices

FDA 510(k) Submission Details - K131778

510(k) Number K131778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2013
Decision Date November 14, 2013
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
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
NCT01113892 Completed Interventional Industry-sponsored

Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.

Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)

207
Patients (actual)
25
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Peripheral Arterial Occlusive Disease
Study design Parallel
Eligibility All sexes · 21 Years+
Principal investigator Alan Lumsden, MD
Sponsor Maquet Cardiovascular (industry)
Started 2010-05-17 → Primary completion 2012-12-18 → Completed 2013-06-04
Primary outcome
Number of Participants With Primary Patency
Secondary outcome
Number of Participants With Primary Assisted Patency
View full study on ClinicalTrials.gov

Regulatory Peers - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 166
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K131778.
Spiral Flow Peripheral Vascular Graft
K150389 · Vascular Flow Technologies, Ltd. · May 2015
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT
K142062 · Vascular Flow Technologies, Ltd. · Nov 2014
SPIRAL FLOW VASCULAR ARTERIOVENOUS GRAFT
K141124 · Vascular Flow Technologies, Ltd. · May 2014
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