Cleared Traditional

K921659 - ULTRA LOW POROSITY DACRON WOVEN PATCH

K921659 is an FDA 510(k) clearance for ULTRA LOW POROSITY DACRON WOVEN PATCH, manufactured by Intervascular, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K921659 · Intervascular, Inc. · Cardiovascular device
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Nov 1992
Decision
232d
Days
Class 2
Risk

K921659 is an FDA 510(k) clearance for the ULTRA LOW POROSITY DACRON WOVEN PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Intervascular, Inc. (Clearwater, US). The FDA issued a Cleared decision on November 25, 1992 after a review of 232 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 Intervascular, Inc. devices

FDA 510(k) Submission Details - K921659

510(k) Number K921659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received April 07, 1992
Decision Date November 25, 1992
Days to Decision 232 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 125d · This submission: 232d
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 78
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K921659.
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
HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC
K931386 · Meadox Medicals, Div. Boston Scientific Corp. · May 1993
TISSUE PATCH, TISSUE GRAFT
K921895 · Bio-Vascular, Inc. · Nov 1992
CARDIOVASCULAR REPAIR PATCH
K905073 · Impra, Inc. · Dec 1991
GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
K914448 · W.L. Gore & Associates, Inc. · Nov 1991