LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061409
    Device Name
    SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
    Manufacturer
    PRECISE MEDICAL PRODUCTS, LTD.
    Date Cleared
    2006-06-16

    (25 days)

    Product Code
    MEB
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISE MEDICAL PRODUCTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The modified SmartInfuser PainPump is intended to provide continuous delivery of a local anesthetic through a catheter inserted directly into the surgical site for postoperative pain management.
    Device Description
    The device comprises of the following parts: - SmartCatheter (optional) - - SmartInfuser set with SmartReg flow regulator, T Check Valve and Multi -Bolus (regulating set) - Compression unit (pump) - - 500 ml infusion bag (empty) - - Peel-off introducer(optional) - - Wound Dressing (Medical adhesive bandage) - - 50/60cc luer lock syringe - - -Medication label - Pump label - Instructions for use - Carrying pouch
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1