Cleared Traditional

GLYCAR PERICARDIAL PATCH (K963967) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963967 · Glycar, Inc. · Cardiovascular device
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Oct 1997
Decision
394d
Days
Class 2
Risk

K963967 is an FDA 510(k) clearance for the GLYCAR PERICARDIAL PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Glycar, Inc. (Dallas, US). The FDA issued a Cleared decision on October 31, 1997 after a review of 394 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 Glycar, Inc. devices

Submission Details

510(k) Number K963967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1996
Decision Date October 31, 1997
Days to Decision 394 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
269d slower than avg
Panel avg: 125d · This submission: 394d
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 22
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K963967.
PRECLUDE PERICARDIAL MEMBRANE
K012098 · W.L. Gore & Associates, Inc. · Sep 2001
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000
ACUSEAL CARDIOVASCULAR PATCH
K984526 · W.L. Gore & Associates, Inc. · Apr 1999
CVPRO CARDIOVASCULAR PATCH
K943736 · W.L. Gore & Associates, Inc. · Feb 1995
GORE-TEX CARDIOVASCULAR PATCH
K940906 · W.L. Gore & Associates, Inc. · May 1994
GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE
K930950 · W.L. Gore & Associates, Inc. · Oct 1993