Cleared Traditional

VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH (K963611) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963611 · Vascutek, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
72d
Days
Class 2
Risk

K963611 is an FDA 510(k) clearance for the VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH.... Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Vascutek, Ltd. (Austin, US). The FDA issued a Cleared decision on November 21, 1996 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vascutek, Ltd. devices

Submission Details

510(k) Number K963611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 9
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K963611.
PremiPatch PTFE Pledget
K151865 · Aesculap, Inc. · Oct 2015
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000
PATCH
K823345 · Shiley, Inc. · Mar 1983
DACRON PLEDGET SUTURE BUTTRESS
K812254 · Ethicon, Inc. · Aug 1981
TEFLON PLEDGET SUTURE BUTTRESS
K811872 · Ethicon, Inc. · Aug 1981