Cleared Traditional

Gelsoft? Plus Vascular Prostheses

K241070 · Vascutek, Ltd. · Cardiovascular
Nov 2024
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K241070 is an FDA 510(k) clearance for the Gelsoft? Plus Vascular Prostheses, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Vascutek, Ltd. (Renfrewshire, GB). The FDA issued a Cleared decision on November 15, 2024, 210 days after receiving the submission on April 19, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K241070 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2024
Decision Date November 15, 2024
Days to Decision 210 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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