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Found 5 results
510(k) Data Aggregation
K Number
K121125Device Name
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Manufacturer
Date Cleared
2012-07-06
(84 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
FLEXIBLE STENTING SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Device Description
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K Number
K120452Device Name
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Manufacturer
Date Cleared
2012-04-24
(70 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
FLEXIBLE STENTING SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Device Description
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K Number
K112522Device Name
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
Manufacturer
Date Cleared
2011-12-30
(121 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
FLEXIBLE STENTING SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FlexStent® Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Device Description
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K Number
K102519Device Name
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
Manufacturer
Date Cleared
2010-11-22
(81 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
FLEXIBLE STENTING SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K081996Device Name
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
Manufacturer
Date Cleared
2009-09-15
(428 days)
Product Code
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
FLEXIBLE STENTING SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FlexStent® Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.
Device Description
Not Found
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