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

    MICRO-GUIDE SYSTEM

    K Number: K884337 · Decision Jan 5, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    40
    Applicant Total
    8
    Review Days
    83

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    Basic Information

    Device Name
    MICRO-GUIDE SYSTEM
    K Number
    K884337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Catheter Research C/O Burditt, Bowles & Radzius
    Date Received
    October 14, 1988
    Decision Date
    January 5, 1989
    Product Code
    DRA
    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
    DRA Catheter, Steerable

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    Other Clearances by Catheter Research C/O Burditt, Bowles & Radzius

    K Number Device Name
    K924227 CRI CYNOSAR CATHETER
    K924125 CRI ELECTRONIC CONTROL SYSTEM
    K914523 CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL
    K904785 CRI CYNOSAR CATHETER
    K904787 CRI STEERABLE CATHETER CONTROL SYSTEM
    K900320 CRI CYNOSAR CATHETER
    K870700 MICRO-GUIDE