Cleared Traditional

Vascutek Gelsoft Plus ERS Vascular Graft

K202703 · Vascutek, Ltd. · Cardiovascular
Apr 2021
Decision
202d
Days
Class 2
Risk

About This 510(k) Submission

K202703 is an FDA 510(k) clearance for the Vascutek Gelsoft Plus ERS Vascular Graft, 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 April 6, 2021, 202 days after receiving the submission on September 16, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K202703 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2020
Decision Date April 06, 2021
Days to Decision 202 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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