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510(k) Data Aggregation

    K Number
    K992664
    Device Name
    TFX MEDICAL STYLET CATHETER
    Manufacturer
    TFX MEDICAL GROUP
    Date Cleared
    2000-04-13

    (248 days)

    Product Code
    DRB
    Regulation Number
    870.1380
    Why did this record match?
    Applicant Name (Manufacturer) :

    TFX MEDICAL GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use in conjunction with catheters or other devices, which require the aid of a stylet to render it stiff for placement.
    Device Description
    The TFX Medical Hydrophilic Coated or Uncoated Stylet consists of a hub which is bonded to the flexible stainless steel shaft.
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    K Number
    K991647
    Device Name
    TFX MEDICAL INTRODUCER KIT
    Manufacturer
    TFX MEDICAL GROUP
    Date Cleared
    2000-01-04

    (236 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    TFX MEDICAL GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.
    Device Description
    The TFX Medical Introducer Kit consists of a Sheath/Dilator Assembly, Needle with indicator, Syringe, Guide-wire Tray
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    K Number
    K963320
    Device Name
    TFX MEDICAL GUIDEWIRE
    Manufacturer
    TFX MEDICAL GROUP
    Date Cleared
    1996-12-03

    (102 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    TFX MEDICAL GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel excluding use in coronary arteries and in the neurovasculature.
    Device Description
    TFX Medical will supply a standard range of guidewires as sterile, packed finished products, and will also supply in bulk to other manufacturer to their specific size requirements (for example: for inclusion in a kit). The kev features of the TFX Medical Guidewire are: - O Core Wire - O Ribbon Wire (where fitted) - O Spring Wire - O Welds - Coating (p.t.f.e. coating or uncoated stainless steel) - Tips (available straight and "J" forms, one or two tips) Guidewires will be manufactured of grade 302/304 stainless steel and be available: - . with and without a ribbon wire - ♥ in fixed and moveable core designs - . uncoated and p.t.f.e. coated - with straight and "J" formed end(s) - with and without a length marking
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