Cleared Traditional

FLUORO-TEX CARDIOVASCULAR PATCH (K994032) - FDA 510(k) Clearance

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

K994032 · Bridger Biomed, Inc. · Cardiovascular device
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Jul 2000
Decision
224d
Days
Class 2
Risk

K994032 is an FDA 510(k) clearance for the FLUORO-TEX CARDIOVASCULAR PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Bridger Biomed, Inc. (Bozeman, US). The FDA issued a Cleared decision on July 7, 2000 after a review of 224 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 Bridger Biomed, Inc. devices

Submission Details

510(k) Number K994032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date July 07, 2000
Days to Decision 224 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
99d slower than avg
Panel avg: 125d · This submission: 224d
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 89
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K994032.
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PremiPatch PTFE Pledget
K151865 · Aesculap, Inc. · Oct 2015
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000
DACRON PLEDGET SUTURE BUTTRESS
K812254 · Ethicon, Inc. · Aug 1981