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510(k) Data Aggregation

    K Number
    K013154
    Device Name
    MARK II/MARK III MANOMETRIC PERFUSION PUMP
    Date Cleared
    2001-10-19

    (29 days)

    Product Code
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSLEEVE PTY., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied: 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.
    Device Description
    When used in conjunction with a gastrointestinal manometric assembly (catheter), the Manometric Perfusion Pump can be used where gastrointestinal manometry is indicated when the following conditions are satisfied: 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastrointestinal motility. 2) Contraindications are considered, and the risk-benefit analysis is judged to favor performance of the manometric study, after measures have been taken to minimize all possible risks.
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    K Number
    K983665
    Device Name
    MANOMETRIC ASSEMBLIES
    Date Cleared
    1999-05-17

    (210 days)

    Product Code
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSLEEVE PTY., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Use of Dentsleeve Manometric Assemblies is indicated when measurements of gastrointestinal tract pressures are judged to be useful for determining management of adults, children & infants with proven or suspected gastrointestinal motor disorders.
    Device Description
    Dentsleeve Manometric Assemblies are designed for the monitoring and analysis of gastrointestinal pressures. They are designed to be used in conjunction with a low compliance manometric perfusion pump. The major structures of the Manometric Assemblies is a multi-channeled, medical grade, silicone rubber extrusion. The Assemblies are designed with variations in length and channel number (depending on the extrusion and application) to enable precise low compliance pressure measurement from most areas of the GI tract. When attached to a manometric perfusion pump, a constant flow of perfused into the assembly and into the GI tract of the patient provided the perfusion pump is correctly operated. When the pressure changes within the GI tract the pressure is transferred faithfully up the assembly and detected with external pressure transducers mounted on the manometric perfusion pump.
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    K Number
    K980946
    Device Name
    MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOMETRIC PERFUSION PUMP
    Date Cleared
    1998-06-08

    (87 days)

    Product Code
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTSLEEVE PTY., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When used in conjunction with a gastrointestinal manometric assembly (catheter), the Mark II CO2 Manometric Perfusion Pump & Mark II Manometric Perfusion Fump, can be used where gastrointestinal manometry is indicated when the following conditions are satisfied; 1) When information about patterns of gastrointestinal pressures is judged to be of importance for either determining appropriate patient management or for research studies into gastro-intestinal motility. 2) Contra-indications are considered, and the risk-bencht analysis is judged to favour performance of the manometric study, after measures have been taken to minimise all possible risks.
    Device Description
    The Mark II Manometric Perfusion Pump and the Mark II CO2 Flush Manometric Perfusion Pump are gas powered perfusion pumps designed to facilitate the monitoring and analysis of intragastrointestinal pressures. The Mark II Manometric Perfusion Pump and the Mark II CO2 Flush Manometric Perfusion Pump are comprised of a constant gas pressure delivery system and a constant flow constant pressure, multi-channel, perfusate system with the capacity to connect pressure transducers for monitoring intragastrointestinal pressures. The Mark II CO2 Flush Manometric Perfusion Pump has an addition CO2 gas circuit for facilitating the removal of air bubbles from the perfusate circuit prior to it clinical use. Both Manometric Perfusion Pump have been designed to be compatible with gastrointestinal motility catheters.
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