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

    MODIFICATION TO SOAKER CATHETER

    K Number: K043456 · Decision Jan 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    41
    Review Days
    27

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    Basic Information

    Device Name
    MODIFICATION TO SOAKER CATHETER
    K Number
    K043456
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Flow Corp.
    Date Received
    December 15, 2004
    Decision Date
    January 11, 2005
    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 I-Flow Corp.

    K Number Device Name
    K063530 ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
    K063234 ON-Q INTRODUCERS
    K051401 ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
    K052117 I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
    K040337 I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
    K023883 HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
    K023827 PARAGON INFUSION SYSTEM WITH BOLUS
    K023318 I-FLOW ELASTOMERIC PUMP WITH BOLUS
    K022869 SOAKER CATHETER
    K020862 I-FLOW ELASTOMERIC PUMP
    Search all 41 clearances from I-Flow Corp. →