Cleared Traditional

Gelweave? Vascular Prostheses

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

About This 510(k) Submission

K241550 is an FDA 510(k) clearance for the Gelweave? Vascular Prostheses, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Inchinnan, GB). The FDA issued a Cleared decision on February 27, 2025, 272 days after receiving the submission on May 31, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K241550 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3450

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