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

    CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L

    K Number: K022553 · Decision Aug 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    104
    Applicant Total
    8
    Review Days
    18

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    Basic Information

    Device Name
    CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
    K Number
    K022553
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1620
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Neurosciences
    Date Received
    August 2, 2002
    Decision Date
    August 20, 2002
    Product Code
    GWM
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GWM Device, Monitoring, Intracranial Pressure

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    Other Clearances by Integra Neurosciences

    K Number Device Name
    K082250 AURAGEN CORTICAL SURFACE ELECTRODES
    K050720 NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
    K031086 CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
    K021989 SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
    K022554 MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
    K020558 LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
    K002765 LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE