FLUORO-TEX SURGICAL MEMBRANE— 510(k) K973178

Name: FDA 510(k) clearance K973178
Creator: U.S. Food and Drug Administration
Published: 1997-11-24

Substantially Equivalent

Bridger Biomed, Inc.

FDA 510(k) clearance K973178 for FLUORO-TEX SURGICAL MEMBRANE, Substantially Equivalent on 1997-11-24. Applicant: Bridger Biomed, Inc.. Device class: 2.

Clearance details

Applicant: Bridger Biomed, Inc.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 1997-08-25
Decision date: 1997-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bozeman, MT, US

Download summary PDF View on FDA.gov ↗

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K003906 — MODIFICATION TO FLUROTEX SURGICAL MESH2001-01-26
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K002351 — FLUOROTEX II SURGICAL MESH2000-08-26
K994032 — FLUORO-TEX CARDIOVASCULAR PATCH2000-07-07
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Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.