Cleared Traditional

PERI-GUARD PERICARDIAL PATCH-HERNIA (K833021) - FDA 510(k) Clearance

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

K833021 · Genetic · Cardiovascular device
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Dec 1983
Decision
111d
Days
Class 2
Risk

K833021 is an FDA 510(k) clearance for the PERI-GUARD PERICARDIAL PATCH-HERNIA. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Genetic (Mchenry, US). The FDA issued a Cleared decision on December 26, 1983 after a review of 111 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K833021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date December 26, 1983
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
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 K833021.
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
GORE-TES EXPANDED PTFE PATCH
K821717 · W.L. Gore & Associates, Inc. · Jan 1983