Cleared Traditional

K994032 - FLUORO-TEX CARDIOVASCULAR PATCH

K994032 is an FDA 510(k) clearance for FLUORO-TEX CARDIOVASCULAR PATCH, manufactured by Bridger Biomed, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K994032 · Bridger Biomed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K994032

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.

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 56
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K994032.
SURGISIS PERIPHERAL VASCULAR PATCH
K001785 · Cook Biotech, Inc. · Dec 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000
CHASE CARDIOVASCULAR PATCH
K001662 · Chase Medical, Inc. · Aug 2000
UNI-GRAFT K DV PATCH
K992776 · Atrium Medical Corp. · Nov 1999
ACUSEAL CARDIOVASCULAR PATCH
K984526 · W.L. Gore & Associates, Inc. · Apr 1999
CV PERI-GUARD AND VASCU-GUARD
K983602 · Bio-Vascular, Inc. · Nov 1998