Cleared Traditional

K252277 - Spiral Laminar Flow Vascular Arterioven...

K252277 is an FDA 510(k) clearance for Spiral Laminar Flow Vascular Arterioven..., manufactured by Vascular Flow Technologies Limited. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K252277 · Vascular Flow Technologies Limited · Cardiovascular device
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Oct 2025
Decision
90d
Days
Class 2
Risk

K252277 is an FDA 510(k) clearance for the Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645). Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascular Flow Technologies Limited (Dundee, GB). The FDA issued a Cleared decision on October 20, 2025 after a review of 90 days - within the typical 510(k) review window.

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 Vascular Flow Technologies Limited devices

FDA 510(k) Submission Details - K252277

510(k) Number K252277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2025
Decision Date October 20, 2025
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K252277.
Fusion Bioline Vascular Graft
K252445 · Maquet Cardiovascular, LLC · Apr 2026
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