Cleared Traditional

K830863 - HANCOCK PERICARDIAL PATCH

K830863 is an FDA 510(k) clearance for HANCOCK PERICARDIAL PATCH, manufactured by Extracorporeal Medical Specialities, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K830863 · Extracorporeal Medical Specialities, Inc. · Cardiovascular device
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Aug 1983
Decision
166d
Days
Class 2
Risk

K830863 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 August 31, 1983 after a review of 166 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 Extracorporeal Medical Specialities, Inc. devices

FDA 510(k) Submission Details - K830863

510(k) Number K830863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1983
Decision Date August 31, 1983
Days to Decision 166 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
41d slower than avg
Panel avg: 125d · This submission: 166d
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 53
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K830863.
PERICARDIAL PATCH
K833763 · American Edwards Laboratories · Nov 1984
HANCOCK PERICARDIAL PATCH
K840262 · Extracorporeal Medical Specialities, Inc. · May 1984
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