Cleared Traditional

K830806 - VASCULAR GRAFT/BIFURCATED/FEP-RINGED

K830806 is the FDA 510(k) clearance for VASCULAR GRAFT/BIFURCATED/FEP-RINGED by W.L. Gore & Associates, Inc.. It is a Class 2 Cardiovascular device (product code DXZ) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K830806 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Aug 1983
Decision
152d
Days
Class 2
Risk

K830806 is an FDA 510(k) clearance for the VASCULAR GRAFT/BIFURCATED/FEP-RINGED. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1983 after a review of 152 days - an extended review 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: 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 K830806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1983
Decision Date August 13, 1983
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K830806.
HANCOCK PERICARDIAL PATCH
K840262 · Extracorporeal Medical Specialities, Inc. · May 1984
GORE-TEX SURGICAL MEMBRANE
K831516 · W.L. Gore & Associates, Inc. · Jan 1984
HANCOCK PERICARDIAL PATCH
K830863 · Extracorporeal Medical Specialities, Inc. · Aug 1983
PATCH
K823345 · Shiley, Inc. · Mar 1983
GORE-TES EXPANDED PTFE PATCH
K821717 · W.L. Gore & Associates, Inc. · Jan 1983
GORE-TEX CARDIOVASCULAR PATCH
K811841 · W.L. Gore & Associates, Inc. · Sep 1981