Cleared Traditional

K823345 - PATCH

K823345 is an FDA 510(k) clearance for 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 122-day FDA review.

K823345 · Shiley, Inc. · Cardiovascular device
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Mar 1983
Decision
122d
Days
Class 2
Risk

K823345 is an FDA 510(k) clearance for the PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1983 after a review of 122 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K823345

510(k) Number K823345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1982
Decision Date March 10, 1983
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 K823345.
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
GORE-TES EXPANDED PTFE PATCH
K821717 · W.L. Gore & Associates, Inc. · Jan 1983
GORE-TEX CARDIOVASCULAR PATCH
K811841 · W.L. Gore & Associates, Inc. · Sep 1981
DACRON PLEDGET SUTURE BUTTRESS
K812254 · Ethicon, Inc. · Aug 1981