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510(k) Data Aggregation

    K Number
    K013855
    Device Name
    MICROJET CRONO H
    Manufacturer
    CANE S.R.I.
    Date Cleared
    2002-05-09

    (170 days)

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

    CANE S.R.I.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The portable Crono infusion device has been designed only for use in subcutaneous and intravenous infusion of prescribed liquid medicines.
    Device Description
    Canè s.r.l., a company that specializes in the production of ambulatory pumps, has now produced a new generation of compact pumps: Crono H, a perfect combination of high technology and innovative design. The infusion pumps which use normal commercial syringes are inevitably cumbersome and thus difficult to use in everyday life. This provokes in the patients a refuse of the therapy. A special syringe, an integral part of the Crono H allows an efficient reduction of the pump size. In this way, the patients can freely carry out the therapy at any time of the day, even during their everyday life. Patients who have been following a iron chelation therapy for a long time, often experience difficulties in absorbing the drug subcutaneously; this may lead to a catheter occlusion with consequent interruption of the infusion. Crono H has a particular mechanism which pushes directly the rubber syringe piston: so it is possible to reach a thrust force up to 3 times higher with respect to conventional pumps. In case of catheter occlusion, an innovative infusion control system makes it possible to proceed with the infusion automatically and, after the occlusion is eliminated, to complete it. For a better absorption of the drug, Crono H makes the infusion up to 3 times more fractionated with respect to traditional pumps (22 ml per impulse, using a 10/20 ml syringe). Crono H is fitted with a liquid crystal display which shows the time it takes to complete the delivery and battery charge status.
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    K Number
    K013776
    Device Name
    MICROJET MODEL # CD4 AND CD4/20
    Manufacturer
    CANE S.R.I.
    Date Cleared
    2002-04-26

    (164 days)

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

    CANE S.R.I.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The portable CD4, CD4/20 infusion devices have been designed only for use in subcutaneous infusion of prescribed liquid medicines.
    Device Description
    This infusion device has been manufactured since 1978 and has, during all this time, proved to be highly reliable in terms of sturdiness, reliability, accuracy and easy operation. Moreover, it does not require particular maintenance work. Microjet CD4 is a portable, battery-operated infusion device for use with 5 ml and 10 ml syringes (20 ml syringes are used with model CD4/20). A special micromotor actuates mechanical members that transform the motor rotary motion into the pusher linear motion which, in turn, causes the syringe piston to advance. The infusion device operating features enable to make infusions with varying amounts of medicine and different infusion times. During infusion, the motor is controlled by a special electronic circuit with regular pulses; therefore, infusion is carried out by delivering small amounts of medicine repeated with the passing of time.
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