Cleared Traditional

Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch

K200955 · Vascutek, Ltd. · Cardiovascular
Jul 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K200955 is an FDA 510(k) clearance for the Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch, a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II — Special Controls, product code DXZ), submitted by Vascutek, Ltd. (Inchinnan, GB). The FDA issued a Cleared decision on July 8, 2020, 90 days after receiving the submission on April 9, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number K200955 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2020
Decision Date July 08, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3470

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