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

    AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH

    K Number: K102460 · Decision Jan 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    4
    Review Days
    139

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    Basic Information

    Device Name
    AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
    K Number
    K102460
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Summit Medical Products, Inc.
    Date Received
    August 27, 2010
    Decision Date
    January 13, 2011
    Product Code
    BSO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSO Catheter, Conduction, Anesthetic

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    Other Clearances by Summit Medical Products, Inc.

    K Number Device Name
    K162165 ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
    K113043 DIRECT ANTIBIOTIC INFUSION KIT
    K110814 AMBIT TUNNELER