Cleared Traditional

Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts

K162803 · Vascutek, Ltd. · Cardiovascular
Jul 2017
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K162803 is an FDA 510(k) clearance for the Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts, 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 July 14, 2017, 282 days after receiving the submission on October 5, 2016. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K162803 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2016
Decision Date July 14, 2017
Days to Decision 282 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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