Cleared Traditional

K842144 - GORE-TEX VASCULAR GRAFT

K842144 is the FDA 510(k) clearance for GORE-TEX VASCULAR GRAFT by W.L. Gore & Associates, Inc.. It is a Class 2 Cardiovascular device (product code DYF) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K842144 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Oct 1984
Decision
124d
Days
Class 2
Risk

K842144 is an FDA 510(k) clearance for the GORE-TEX VASCULAR GRAFT, FEP-RINGED. Classified as Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Walker, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 124 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

Submission Details

510(k) Number K842144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1984
Decision Date October 01, 1984
Days to Decision 124 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
1d faster than avg
Panel avg: 125d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYF Prosthesis, Vascular Graft, Of Less Then 6mm 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 - DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

All 14
Devices cleared under the same product code (DYF) and FDA review panel - the closest regulatory comparables to K842144.
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
K940824 · W.L. Gore & Associates, Inc. · May 1994
FEP RINGED GORE-TEX VASCULAR GRAFT
K934726 · W.L. Gore & Associates, Inc. · Dec 1993
GORE-TEX VASCULAR GRAFT
K881732 · W.L. Gore & Associates, Inc. · May 1988
FEP-RINGED GORE-TEX@ VASCULAR GRAFT
K821826 · W.L. Gore & Associates, Inc. · Dec 1982