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

    REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

    K Number: K033436 · Decision Mar 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    29
    Applicant Total
    36
    Review Days
    505

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    Basic Information

    Device Name
    REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
    K Number
    K033436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alliance Medical Corp.
    Date Received
    October 28, 2003
    Decision Date
    March 16, 2005
    Product Code
    OWQ
    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
    OWQ Reprocessed Intravascular Ultrasound Catheter

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    Other Clearances by Alliance Medical Corp.

    K Number Device Name
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    K053316 REPROCESSED COMPRESSION SLEEVES
    K052918 REPROCESSED EXTERNAL FIXATION DEVICES
    K052603 REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
    K052414 REPROCESSED ELECTROPHYSIOLOGY CATHETER
    K052064 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
    K052062 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
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