Cleared Traditional

PERI-GUARD PERICARDIAL PATCH (K842066) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842066 · Genetic Laboratories, Inc. · Cardiovascular device
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Dec 1985
Decision
616d
Days
Class 2
Risk

K842066 is an FDA 510(k) clearance for the PERI-GUARD PERICARDIAL PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Genetic Laboratories, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 30, 1985 after a review of 616 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Genetic Laboratories, Inc. devices

Submission Details

510(k) Number K842066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date December 30, 1985
Days to Decision 616 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
491d slower than avg
Panel avg: 125d · This submission: 616d
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 23
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K842066.
GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
K914450 · W.L. Gore & Associates, Inc. · Nov 1991
GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
K912107 · W.L. Gore & Associates, Inc. · Oct 1991
GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
K910464 · W.L. Gore & Associates, Inc. · Mar 1991
GORE-TEX SURGICAL MEMBRANE
K831516 · W.L. Gore & Associates, Inc. · Jan 1984
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
K830806 · W.L. Gore & Associates, Inc. · Aug 1983
PATCH
K823345 · Shiley, Inc. · Mar 1983