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

    QUATTRO CATHETER MODEL IC4593

    K Number: K070161 · Decision Feb 15, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    QUATTRO CATHETER MODEL IC4593
    K Number
    K070161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alsius Corp.
    Date Received
    January 17, 2007
    Decision Date
    February 15, 2007
    Product Code
    NCX
    Advisory Committee
    Cardiovascular
    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
    NCX System, Hypothermia, Intravenous, Cooling

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    Other Clearances by Alsius Corp.

    K Number Device Name
    K081936 SOLEX CATHETER, MODEL SL2593
    K072234 THERMOGARD XP THERMAL REGULATION SYSTEM
    K063829 THERMOGARD THERMAL REGULATION SYSTEM
    K060308 COOLGARD 3000
    K052443 ICY CATHETER, MODEL IC-3893A
    K051912 COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B
    K030421 ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
    K014241 COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D