Cleared Traditional

K991602 - EPTFE RINGED GORE-TEX VASCULAR GRAFT

K991602 is an FDA 510(k) clearance for EPTFE RINGED GORE-TEX 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 60-day FDA review.

K991602 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1999
Decision
60d
Days
Class 2
Risk

K991602 is an FDA 510(k) clearance for the EPTFE RINGED GORE-TEX 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 July 9, 1999 after a review of 60 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 - K991602

510(k) Number K991602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1999
Decision Date July 09, 1999
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
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 K991602.
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
K992832 · Sulzermedica · Nov 1999
ADVANTA GRAFT (>6MM)
K992960 · Atrium Medical Corp. · Oct 1999
ADVANTA GRAFT
K992443 · Atrium Medical Corp. · Aug 1999
UNI-GRAFT K DV VASCULAR GRAFT
K991813 · Atrium Medical Corp. · Jun 1999
BI-DIRECTIONAL TUNNELER
K991027 · Impra, Inc. · Apr 1999
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K984294 · Intervascular, Inc. · Feb 1999