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510(k) Data Aggregation
K Number
K003906Device Name
MODIFICATION TO FLUROTEX SURGICAL MESH
Manufacturer
Date Cleared
2001-01-26
(38 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRIDGER BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K003917Device Name
MODIFICATION TO FLUOROTEX II SURGICAL MESH
Manufacturer
Date Cleared
2001-01-26
(38 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRIDGER BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K002351Device Name
FLUOROTEX II SURGICAL MESH
Manufacturer
Date Cleared
2000-08-26
(24 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRIDGER BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K994032Device Name
FLUORO-TEX CARDIOVASCULAR PATCH
Manufacturer
Date Cleared
2000-07-07
(224 days)
Product Code
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
BRIDGER BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fluoro-Tex™ Cardiovascular Patch is intended to be used for the repair of the cardiovascular system.
Device Description
Fluoro-Tex Cardiovascular Patch consists of a sheet of porous expanded polytetrafluoroethylene (ePTFE) internally reinforced with fluorinated ethylene propylene (FEP).
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K Number
K984197Device Name
FLUOROTEX SURGICAL MESH
Manufacturer
Date Cleared
1999-01-07
(45 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BRIDGER BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FluoroTex™ Surgical Mesh is intended to be used for the repair of soft tissue and the reconstruction of hernias.
Device Description
The FluoroTex Surgical Mesh consists of porous expanded polytetrafluoroethylene (ePTFE) reinforced with fluorinated ethylene propylene (FEP).
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K Number
K980548Device Name
DURA-PATCH MODEL DP-XXX
Manufacturer
Date Cleared
1998-05-13
(90 days)
Product Code
Regulation Number
882.5910Why did this record match?
Applicant Name (Manufacturer) :
BRIDGER BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bridger Biomed Dura-Patch™ is intended for replacement or repair of the dura.
Device Description
Dura-Patch™ Dura Substitute is a 100% ePTFE membrane, which is intended to be used as a replacement for dura tissue deficiencies.
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K Number
K973178Device Name
FLUORO-TEX SURGICAL MEMBRANE
Manufacturer
Date Cleared
1997-11-24
(91 days)
Product Code
Regulation Number
870.3470Why did this record match?
Applicant Name (Manufacturer) :
BRIDGER BIOMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fluoro-Tex154 Surgical Membrane is an implant material which is intended to be used for the repair or replacement of the peritoneum and pericardium.
Device Description
The Bridger Biomed Fluoro-Tex™ Surgical Membrane is substantially equivalent to Gore-Tex® Surgical Membrane. Both devices consist of a sheet of porous expanded polytetrafluoroethylene (ePTFE), approximately 0.1 millimeters thick. The Fluoro-TexTM Surgical Membrane and the predicate device are intended for the repair or replacement of the peritoneum.
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