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510(k) Data Aggregation

    K Number
    K192408
    Device Name
    Custodiol HTK Solution
    Manufacturer
    Dr. Franz Kohler Chemie GmbH
    Date Cleared
    2020-04-24

    (233 days)

    Product Code
    KDL, MSB
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dr. Franz Kohler Chemie GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CUSTODIOL® HTK solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the patient. CUSTODIOL® HTK solution is not indicated for continuous machine perfusion of donor organs.
    Device Description
    The CUSTODIOL® HTK solution is intended for perfusion and flushing donor kidney, liver, heart, and pancreas prior to removal from the donor and for preserving these organs during hypothermic storage and transport to the recipient. CUSTODIOL® HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the CUSTODIOL® HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the CUSTODIOL® HTK solution occur naturally in the body. The CUSTODIOL® HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in orqans that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The CUSTODIOL® HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.
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    K Number
    K043461
    Device Name
    CUSTODIOL
    Manufacturer
    DR. FRANZ KOHLER CHEMIE GMBH
    Date Cleared
    2005-02-28

    (75 days)

    Product Code
    KDL
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. FRANZ KOHLER CHEMIE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
    Device Description
    The HTK solution is intended for perfusion and flushing donor kidney, liver, heart, and pancreas prior to removal from the donor and for preserving these organs during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This allows the organ to be quickly cooled.
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    K Number
    K032794
    Device Name
    CUSTODIOL
    Manufacturer
    DR. FRANZ KOHLER CHEMIE GMBH
    Date Cleared
    2004-04-05

    (210 days)

    Product Code
    MSB
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. FRANZ KOHLER CHEMIE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, livers, and hearts prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
    Device Description
    The HTK solution is intended for perfusion and flushing donor hearts prior to removal from the donor and for preserving the heart during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.
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    K Number
    K020924
    Device Name
    CUSTODIOL HTK SOLUTION
    Manufacturer
    DR. FRANZ KOHLER CHEMIE GMBH
    Date Cleared
    2003-01-06

    (291 days)

    Product Code
    KDL
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. FRANZ KOHLER CHEMIE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys and liver prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
    Device Description
    The HTK solution is intended for perfusion and flushing donor kidneys and liver prior to removal from the donor and for preserving the kidney during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCI, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.
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    K Number
    K992209
    Device Name
    CUSTODIOL
    Manufacturer
    DR. FRANZ KOHLER CHEMIE GMBH
    Date Cleared
    1999-12-10

    (163 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    DR. FRANZ KOHLER CHEMIE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
    Device Description
    The HTK solution is intended for perfusion and flushing donor kidneys prior to removal from the donor and for preserving the kidney during hypothermic storage and transport to the recipient. HTK solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive buffering of the extracellular space by means of histidine/histidine HCl, so as to prolong the period for which the organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the HTK solution is due to the sodium and potassium. The composition of HTK is similar to that of extracellular fluid. All of the components of the HTK solution occur naturally in the body. The HTK solution is relatively low in potassium concentration so that residual solution in the transplanted organ poses no danger to the recipient. This is particularly important in organs that take up relatively large amounts of the perfusate, which may find its way into the recipient's circulation. The HTK solution has a low viscosity, even at low temperatures. This characteristic assures rapid flow rates during initial perfusion, allowing the organ to be quickly cooled.
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