Cleared Traditional

K131778 - FUSION VASCULAR GRAFT AND FUSION BIOLIN...

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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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
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 126
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K131778.
HeRO Graft
K172637 · Merit Medical Systems, Inc. · Nov 2017
Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts
K162803 · Vascutek, Ltd. · Jul 2017
Gelweave Vascular Grafts
K162794 · Vascutek, Ltd. · Jun 2017
GORE ACUSEAL VASCULAR GRAFT
K130215 · W.L. Gore & Associates, Inc. · Apr 2013
LIFESPAN EPTFE VASCULAR GRAFT
K130016 · LeMaitre Vascular, Inc. · Feb 2013
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · Atrium Medical Corp. · Aug 2012