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

    COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D

    K Number: K014241 · Decision Aug 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    9
    Review Days
    583

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
    K Number
    K014241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Alsius Corp.
    Date Received
    December 26, 2001
    Decision Date
    August 1, 2003
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NCX), ordered by most recent decision date.

    Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEMPEDY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hypocore

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Alsius Corp.

    K Number Device Name
    K081936 SOLEX CATHETER, MODEL SL2593
    K072234 THERMOGARD XP THERMAL REGULATION SYSTEM
    K070161 QUATTRO CATHETER MODEL IC4593
    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