Cleared Traditional

K964467 - SHELHIGH PERICARDIAL PATCH

K964467 is an FDA 510(k) clearance for SHELHIGH PERICARDIAL PATCH, manufactured by Shelhigh, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K964467 · Shelhigh, Inc. · Cardiovascular device
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Sep 1997
Decision
320d
Days
Class 2
Risk

K964467 is an FDA 510(k) clearance for the SHELHIGH PERICARDIAL PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Shelhigh, Inc. (Millburn, US). The FDA issued a Cleared decision on September 23, 1997 after a review of 320 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 Shelhigh, Inc. devices

FDA 510(k) Submission Details - K964467

510(k) Number K964467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1996
Decision Date September 23, 1997
Days to Decision 320 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 125d · This submission: 320d
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 55
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K964467.
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
K972201 · Sulzer Carbomedics, Inc. · Apr 1998
CV PERI-GUARD - CARDIOVASCULAR PATCH
K971726 · Bio-Vascular, Inc. · Apr 1998
FLUORO-TEX SURGICAL MEMBRANE
K973178 · Bridger Biomed, Inc. · Nov 1997
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH
K963611 · Vascutek, Ltd. · Nov 1996
HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
K962342 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1996
HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC
K955349 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1996