Cleared Traditional

K252445 - Fusion Bioline Vascular Graft

K252445 is an FDA 510(k) clearance for Fusion Bioline Vascular Graft, 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 266-day FDA review.

K252445 · Maquet Cardiovascular, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K252445

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.

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 152
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