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

    ANGIOSCOPE

    K Number: K865017 · Decision Dec 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    8
    Review Days
    357

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    Basic Information

    Device Name
    ANGIOSCOPE
    K Number
    K865017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mansfield Scientific, Inc.
    Date Received
    December 23, 1986
    Decision Date
    December 15, 1987
    Product Code
    DQX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQX Wire, Guide, Catheter

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    Other Clearances by Mansfield Scientific, Inc.

    K Number Device Name
    K870186 ENDOMYOCARDIAL BIOPSY DEVICE
    K855103 CIRIBART GYUDUBG CATGETER
    K853850 EXPLORER
    K852797 HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE
    K851848 PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER
    K844752 TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA
    K841705 WEDGE PRESSURE CATHETER FLOW DIRECTED