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

    PARAGON BOLUS ACCESSORY SET

    K Number: K984638 · Decision Feb 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    41
    Review Days
    40

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    Basic Information

    Device Name
    PARAGON BOLUS ACCESSORY SET
    K Number
    K984638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I-Flow Corp.
    Date Received
    December 31, 1998
    Decision Date
    February 9, 1999
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPA Set, Administration, Intravascular

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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)
    K043456 MODIFICATION TO SOAKER CATHETER
    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
    Search all 41 clearances from I-Flow Corp. →