Cleared Traditional

K241550 - Gelweave™ Vascular Prostheses (FDA 510(k) Clearance)

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

K241550 · Vascutek, Ltd. · Cardiovascular device
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Feb 2025
Decision
272d
Days
Class 2
Risk

K241550 is an FDA 510(k) clearance for the Gelweave™ Vascular Prostheses. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascutek, Ltd. (Inchinnan, GB). The FDA issued a Cleared decision on February 27, 2025 after a review of 272 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 Vascutek, Ltd. devices

Submission Details

510(k) Number K241550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2024
Decision Date February 27, 2025
Days to Decision 272 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
147d slower than avg
Panel avg: 125d · This submission: 272d
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 Consultant

Bolton Medical Inc. (Dba Terumo Aortic)
Miriam Paret

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K241550.
Fusion Bioline Vascular Graft
K252445 · Maquet Cardiovascular, LLC · Apr 2026
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
K252277 · Vascular Flow Technologies Limited · Oct 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