Cleared Traditional

K914447 - GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE

K914447 is an FDA 510(k) clearance for GORE-TEX VASCULAR GRAFTS, 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 32-day FDA review.

K914447 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Nov 1991
Decision
32d
Days
Class 2
Risk

K914447 is an FDA 510(k) clearance for the GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE. 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 November 5, 1991 after a review of 32 days - a notably fast clearance cycle.

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: 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 W.L. Gore & Associates, Inc. devices

FDA 510(k) Submission Details - K914447

510(k) Number K914447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1991
Decision Date November 05, 1991
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
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 K914447.
FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT
K922905 · W.L. Gore & Associates, Inc. · Nov 1992
ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF
K922025 · Pioneering Technologies, Inc. · Sep 1992
PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION
K914116 · Medtronic Vascular · Nov 1991
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
K910863 · Vascutek, Ltd. · Apr 1991
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
K910864 · Vascutek, Ltd. · Apr 1991
TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS
K910865 · Vascutek, Ltd. · Apr 1991