Cleared Traditional

VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH

K963611 · Vascutek, Ltd. · Cardiovascular
Nov 1996
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K963611 is an FDA 510(k) clearance for the VASCUTEK CARDIOVASCULAR FABRIC: 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. (Austin, US). The FDA issued a Cleared decision on November 21, 1996, 72 days after receiving the submission on September 10, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3470.

Submission Details

510(k) Number K963611 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1996
Decision Date November 21, 1996
Days to Decision 72 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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