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510(k) Data Aggregation

    K Number
    K030468
    Device Name
    ACURA ELITE GRAVITY COMPENSATING RESERVOIR
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    2003-10-15

    (245 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for implantation over either right or left frontal horn, in conjunction with a ventricles for the purpose of diagnostic studies, therapeutic drug access to the cord/or diversion of cerebrospinal fluid.
    Device Description
    Accura Elite Gravity Compensating Reservoir
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    K Number
    K024040
    Device Name
    ACCURA ELITE SHUNT SYSTEM
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    2003-01-27

    (52 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Accura Elite Shunt System is intended for use as the principle of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.
    Device Description
    Not Found
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    K Number
    K024101
    Device Name
    PHOENIX UNIVERSAL SHUNT SYSTEM
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    2003-01-27

    (46 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Universal Shunt System is intended for use as the principle pressure-regulating component of a cerebrospinal fluid shunt assembly, used in the treatment of hydrocephalus.
    Device Description
    Not Found
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    K Number
    K021644
    Device Name
    PERF (OMMAYA STYLE) RESERVOIRS
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    2002-08-06

    (78 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - The Perf (Ommaya Style) Reservoir is intended as a means of gaining access to the cerebral ventricles by hypodermic puncture. It may be used for ventricular drainage. - The Perf (Ommaya Style) Reservoir may be used to access the ventricles for the administration of chemotherapeutic agents and/or radioisotopes.
    Device Description
    Not Found
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    K Number
    K002476
    Device Name
    LUMBOPERITONEAL SHUNT SYSTEM
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    2000-11-09

    (90 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000514
    Device Name
    RUMBAR DRAINAGE SYSTEM
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    2000-05-10

    (84 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991429
    Device Name
    DIAMOND II VALVE
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    1999-05-19

    (23 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended as the principle pressure regulating component of a CSF shunt assembly, used regulabing compt of hydrocephalus.
    Device Description
    Not Found
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    K Number
    K990256
    Device Name
    CRX WORLD SHUNT
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    1999-04-01

    (64 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.
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    K Number
    K974096
    Device Name
    CRX DIAMOND VALVE
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    1998-12-08

    (404 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use as the principle regulating component of a CSF ITOW and pressure regaremently, used in the treatment of hydrocephalus.
    Device Description
    Not Found
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    K Number
    K962144
    Device Name
    PHOENIX ETE TISSUE EXTENSION SYSTEM
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    1997-01-14

    (225 days)

    Product Code
    MKY
    Regulation Number
    878.4320
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX BIOMEDICAL CORP.

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

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