Cleared Traditional

K252445 - Fusion Bioline Vascular Graft (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252445 · Maquet Cardiovascular, LLC · Cardiovascular device
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Apr 2026
Decision
266d
Days
Class 2
Risk

K252445 is an FDA 510(k) clearance for the 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 April 27, 2026 after a review of 266 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

Submission Details

510(k) Number K252445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2025
Decision Date April 27, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 187
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K252445.
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
K252277 · Vascular Flow Technologies Limited · Oct 2025
Gelweave™ Vascular Prostheses
K241550 · Vascutek, Ltd. · Feb 2025
Gelsoft™ Plus Vascular Prostheses
K241070 · Vascutek, Ltd. · Nov 2024
Advanta VXT Vascular Graft, Flixene Vascular Graft
K231972 · Atrium Medical Corporation · Mar 2024
GORE® PROPATEN® Vascular Graft
K240083 · W.L. Gore & Associates, Inc. · Mar 2024
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
K233783 · Peca Labs, Inc. · Jan 2024