BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FIBREX CATHETER PATENCY DEVICE

    K Number: K040427 · Decision May 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    46
    Review Days
    74

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    Basic Information

    Device Name
    FIBREX CATHETER PATENCY DEVICE
    K Number
    K040427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Device Technologies, Inc.
    Date Received
    February 19, 2004
    Decision Date
    May 3, 2004
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Medical Device Technologies, Inc.

    K Number Device Name
    K101832 BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
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    K051421 INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
    K050873 CANALIZER HYDROPHILIC GUIDE WIRE
    K043523 INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
    K042464 V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
    K031442 PBN GUIDEWIRES
    K021606 EN-SNARE ENDOVASCULAR SNARE AND CATHETER
    K011790 MICROCRUISER PLUS INTRODUCER SET
    K000620 PBN FALLOPIAN TUBE CATHETER SYSTEM
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