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510(k) Data Aggregation

    K Number
    K111031
    Device Name
    PAINFUSOR CATHETER
    Manufacturer
    PLAN 1 HEALTH, S.R.L.
    Date Cleared
    2011-07-08

    (85 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLAN 1 HEALTH, S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.
    Device Description
    The PAINfusor Catheter is a closed tip multi-holed catheter with a fenestrated length that incorporates micro-holes in a helical pattern that allow for homogenous flow of analgesia into a surgical wound. The PAINfusor Catheter is radiopaque and has graduated markings along the length of the catheter for positional reference. It is supplied and packaged as a kit with a peel-away introducer needle, occlusive wound dressing and catheter securement adhesive.
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