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510(k) Data Aggregation

    K Number
    K023251
    Device Name
    PEDIATRIC ARTERIAL CANNULA
    Manufacturer
    POLYSTAN A/S
    Date Cleared
    2002-12-04

    (65 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYSTAN A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pediatric Arterial Cannula is used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedure.
    Device Description
    The Polystan pediatric arterial cannula is single-use, disposable, sterile and non-pyrogenic device. The cannula has a tapered wire reinforced PVC body with an open beveled distal tip. Three depth indicator marks are positioned at approximately 2 cm intervals from the distal tip. A stylet is incorporated to assist cannulation. The proximal cannula end terminates with either a " /16" or ¼" capped connector incorporating a female luer fitting. The cannulae range in size from 6 Fr. to12 Fr.
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    K Number
    K013038
    Device Name
    SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
    Manufacturer
    POLYSTAN A/S
    Date Cleared
    2002-08-14

    (338 days)

    Product Code
    DTZ
    Regulation Number
    870.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYSTAN A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAFE MAXI – hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.
    Device Description
    SAFE MAXI is a hollow fiber oxygenator with an integral venous heat exchanger. The SAFE MAXI oxygenator is a single-use, disposable, sterile and non-pyrogenic device. The overall blood flow path is from bottom to top in the heat exchanger module and top to bottom in the gas exchange section. The inverted "U" shaped blood flow path optimizes the device's bubble trapping capabilities. Gas exchange occurs by diffusion across the porous hollow fiber membrane.
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    K Number
    K022281
    Device Name
    SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
    Manufacturer
    POLYSTAN A/S
    Date Cleared
    2002-08-06

    (22 days)

    Product Code
    DTN
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYSTAN A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAFE MAXI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and to defoam and filter intra-thoracic suction blood prior to returning it to the extracorporeal circuit.
    Device Description
    SAFE MAXI venous/cardiotomy reservoir is a hard shell reservoir with separate venous and cardiotomy inlets. The venous inlet with 175 micron venous filter is placed at the bottom of the reservoir, which provides a bottom to top venous blood flow. Returning suction blood enters the large surface area 20 micron depth filter at the top of the reservoir. The SAFE MAXI venous/cardiotomy reservoir is single-use, disposable, sterile and non-pyrogenic. The reservoir is a sealed type for vacuum applications. The maximum capacity of the reservoir is 4000 ml.
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    K Number
    K980974
    Device Name
    SAFE MINI
    Manufacturer
    POLYSTAN A/S
    Date Cleared
    2000-10-13

    (942 days)

    Product Code
    DTZ
    Regulation Number
    870.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYSTAN A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAFE MINI hollow fibre oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration. The SAFE MINI venous/cardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and filter and defoam intra-thoracic suction blood prior to returning it to the extracorporeal circuit.
    Device Description
    Not Found
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    K Number
    K953976
    Device Name
    SAFE MICRO
    Manufacturer
    POLYSTAN A/S
    Date Cleared
    1997-02-04

    (531 days)

    Product Code
    DTZ
    Regulation Number
    870.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYSTAN A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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