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510(k) Data Aggregation

    K Number
    K113869
    Device Name
    ORIGEN REINFORCED DUAL LUMEN CATHETER
    Manufacturer
    Origen Biomedical, Inc.
    Date Cleared
    2012-07-26

    (209 days)

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

    Origen Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OriGen Reinforced Dual Lumen cannula is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
    Device Description
    The OriGen Reinforced Dual Lumen catheter (RDLC) is the same design as the OriGen Dual Lumen Catheter (the predicate device), but with the addition of a wire reinforcement layer on the tip of the device. Both are dual lumen catheters with unequal lumen areas for drainage and reinfusion. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. Other characteristics of the catheter are the same.
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    K Number
    K021702
    Device Name
    CRYOBAG, MODEL CB
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Date Cleared
    2002-08-06

    (75 days)

    Product Code
    LPZ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGEN BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OriGen tissue storage bags are indicated for use in protecting, storing and freezing cells and tissues.
    Device Description
    Not Found
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    K Number
    K003288
    Device Name
    ORIGEN DUAL LUMEN CATHETER
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Date Cleared
    2001-06-08

    (231 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGEN BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003145
    Device Name
    ORIGEN BLADDER HOLDER
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Date Cleared
    2001-04-20

    (192 days)

    Product Code
    DWC
    Regulation Number
    870.4250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGEN BIOMEDICAL, INC.

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