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

    CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH

    K Number: K892530 · Decision Sep 26, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    110
    Review Days
    168

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    Basic Information

    Device Name
    CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPH
    K Number
    K892530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Arrow Intl., Inc.
    Date Received
    April 11, 1989
    Decision Date
    September 26, 1989
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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    Other Clearances by Arrow Intl., Inc.

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    K093050 ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
    K071491 ARROW INTERNATIONAL, INC., SURGICAL DRAPES
    K071998 ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT
    K071111 NON-ABSORBABLE SILK SUTURE
    K060309 AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES
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