Cleared Traditional

K963611 - VASCUTEK CARDIOVASCULAR FABRIC: VASCUTE...

K963611 is an FDA 510(k) clearance for VASCUTEK CARDIOVASCULAR FABRIC: VASCUTE..., manufactured by Vascutek, Ltd.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K963611 · Vascutek, Ltd. · Cardiovascular device
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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

FDA 510(k) Submission Details - K963611

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
Combination Product No
PCCP Authorized No
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.

DXZ Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K963611.
ACUSEAL CARDIOVASCULAR PATCH
K984526 · W.L. Gore & Associates, Inc. · Apr 1999
CV PERI-GUARD AND VASCU-GUARD
K983602 · Bio-Vascular, Inc. · Nov 1998
CV PERI-GUARD - CARDIOVASCULAR PATCH
K971726 · Bio-Vascular, Inc. · Apr 1998
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
K962342 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1996
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
K955349 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1996
TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET
K953289 · Davis & Geck, Inc. · Aug 1995