Cleared Traditional

K840262 - HANCOCK PERICARDIAL PATCH

K840262 is the FDA 510(k) clearance for HANCOCK PERICARDIAL PATCH by Extracorporeal Medical Specialities, Inc.. It is a Class 2 Cardiovascular device (product code DXZ) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K840262 · Extracorporeal Medical Specialities, Inc. · Cardiovascular device
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May 1984
Decision
132d
Days
Class 2
Risk

K840262 is an FDA 510(k) clearance for the HANCOCK PERICARDIAL PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Walker, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 132 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.

View all Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K840262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date May 30, 1984
Days to Decision 132 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
7d slower than avg
Panel avg: 125d · This submission: 132d
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 26
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K840262.
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
PERICARDIAL PATCH
K833763 · American Edwards Laboratories · Nov 1984
GORE-TEX SURGICAL MEMBRANE
K831516 · W.L. Gore & Associates, Inc. · Jan 1984
HANCOCK PERICARDIAL PATCH
K830863 · Extracorporeal Medical Specialities, Inc. · Aug 1983
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
K830806 · W.L. Gore & Associates, Inc. · Aug 1983