Cleared Traditional

K833763 - PERICARDIAL PATCH

K833763 is an FDA 510(k) clearance for PERICARDIAL PATCH, manufactured by American Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K833763 · American Edwards Laboratories · Cardiovascular device
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Nov 1984
Decision
372d
Days
Class 2
Risk

K833763 is an FDA 510(k) clearance for the PERICARDIAL PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Cleared decision on November 1, 1984 after a review of 372 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 American Edwards Laboratories devices

FDA 510(k) Submission Details - K833763

510(k) Number K833763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date November 01, 1984
Days to Decision 372 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
247d slower than avg
Panel avg: 125d · This submission: 372d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K833763.
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
WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS
K905496 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1991
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