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510(k) Data Aggregation

    K Number
    K990765
    Device Name
    FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO
    Manufacturer
    FLEXMEDICS
    Date Cleared
    1999-03-15

    (7 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXMEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FlexFinder® ENCAP guidewire is designed to be used to guide and exchange endoscopic accessories and clinical capabilities for biliary procedures. The FlexFinder® guidewire is indicated for selective cannulation of the biliary ducts, including, cystic, pancreatic, and right and left hepatic ducts.
    Device Description
    Not Found
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    K Number
    K964955
    Device Name
    FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING
    Manufacturer
    FLEXMEDICS
    Date Cleared
    1997-02-14

    (65 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLEXMEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FlexFinder® Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder® Guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.
    Device Description
    The FlexFinder® Guidewire is available in a nominal diameter of 0.035" with marked and unmarked models encompassing lengths between 260 - 450 cm. The guidewire is constructed of a Nitinol, kink resistant core wire encapsulated in a PTFE coating. The core wire is tapered to provide flexibility of the distal tip. The guidewire is provided in two shaft flexibility's; regular shaft and stiff shaft. The guidewire will be available in both ink marked and unmarked models of each of the shaft flexibility's. For the marked models, the distal portion of the guidewire is marked visually with ink bands to allow for endoscopic detection of wire movement during a clinical procedure. The encapsulated guidewire enables it to be used with wire guided electrosurgical devices providing insulation from the electrosurgical current during a procedure. The insulation meets the AAMI standard for High frequency Therapeutic devices(HF 18) which describes testing for reliability, safety, and effectiveness. The guidewires are packaged, sterilized, and labeled and intended for one procedure use only(disposable).
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