Cleared Traditional

K801764 - IONESCU-SHILEY PERICARDIAL PATCH

K801764 is an FDA 510(k) clearance for IONESCU-SHILEY PERICARDIAL PATCH, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K801764 · Shiley, Inc. · Cardiovascular device
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Aug 1980
Decision
16d
Days
Class 2
Risk

K801764 is an FDA 510(k) clearance for the IONESCU-SHILEY PERICARDIAL PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 16 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shiley, Inc. devices

FDA 510(k) Submission Details - K801764

510(k) Number K801764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 13, 1980
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
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 50
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K801764.
GORE-TEX CARDIOVASCULAR PATCH
K811841 · W.L. Gore & Associates, Inc. · Sep 1981
DACRON PLEDGET SUTURE BUTTRESS
K812254 · Ethicon, Inc. · Aug 1981
TEFLON PLEDGET SUTURE BUTTRESS
K811872 · Ethicon, Inc. · Aug 1981
SCI MED PERICARDIAL SUBSTITUTE
K791792 · Scimed Life Systems, Inc. · Dec 1979
FELT, SURGICAL DACRON
K760516 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1977