Cleared Traditional

K904282 - BIFURCATED GORE TEX STRETCH VASCULAR GRAFT

K904282 is an FDA 510(k) clearance for BIFURCATED GORE TEX STRETCH VASCULAR GRAFT, manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K904282 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Jan 1991
Decision
120d
Days
Class 2
Risk

K904282 is an FDA 510(k) clearance for the BIFURCATED GORE TEX STRETCH VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on January 16, 1991 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all W.L. Gore & Associates, Inc. devices

FDA 510(k) Submission Details - K904282

510(k) Number K904282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1990
Decision Date January 16, 1991
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 155
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K904282.
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
K910865 · Vascutek, Ltd. · Apr 1991
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS
K910866 · Vascutek, Ltd. · Apr 1991
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
K905067 · Pioneering Technologies, Inc. · Mar 1991
GORE-TEX(R) STRETCH VASCULAR GRAFT
K903931 · W.L. Gore & Associates, Inc. · Dec 1990
AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT
K901641 · W.L. Gore & Associates, Inc. · Sep 1990
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
K901682 · Pioneering Technologies, Inc. · Jul 1990