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

    ARGON CONTINUOUS FLUSH DEVICE

    K Number: K070384 · Decision Mar 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    20
    Review Days
    48

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    Basic Information

    Device Name
    ARGON CONTINUOUS FLUSH DEVICE
    K Number
    K070384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Argon Medical Devices, Inc.
    Date Received
    February 9, 2007
    Decision Date
    March 29, 2007
    Product Code
    KRA
    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
    KRA Catheter, Continuous Flush

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    Other Clearances by Argon Medical Devices, Inc.

    K Number Device Name
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    K232679 Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister
    K233432 10F Sheath and Dilator Set
    K232443 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
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