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510(k) Data Aggregation

    K Number
    K032531
    Device Name
    CHASE CARDIAC ANALYSIS SYSTEM
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2004-02-02

    (171 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from cardiac magnetic resonance image (MRI) studies. This information is presented as both an interactive 3D model and as text reports. The System is designed to automate the segmentation of cardiac structure and calculate anatomical and functional parameters and this information, when interpreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.
    Device Description
    Not Found
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    K Number
    K022093
    Device Name
    CHASE CARDIOVASCULAR PATCH KIT
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2002-09-20

    (85 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHASE Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.
    Device Description
    Not Found
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    K Number
    K021129
    Device Name
    CHARE CARIOVASCULAR PATCH
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2002-06-03

    (56 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHASE Cardiovascular Patch With Radiopaque Markings is indicated for cardiac and vascular patch grafting.
    Device Description
    Not Found
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    K Number
    K020233
    Device Name
    CHASE CARDIOVASCULAR PATCH KIT
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2002-03-14

    (50 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHASE Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.
    Device Description
    Not Found
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    K Number
    K020132
    Device Name
    CHASE CARDIOVASCULAR PATCH KIT
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2002-02-26

    (42 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chase Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.
    Device Description
    Not Found
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    K Number
    K012248
    Device Name
    CHASE CARDIOVASCULAR PATCH
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2001-08-10

    (24 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CHASE Cardiovascular Patch is indicated for use in cardiovascular patching.
    Device Description
    Not Found
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    K Number
    K003467
    Device Name
    CHASE CARDIOVASCULAR PATCH
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2001-01-29

    (82 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001662
    Device Name
    CHASE CARDIOVASCULAR PATCH
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    2000-08-02

    (63 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972993
    Device Name
    CHASE FEMORAL ACCESS CANNULATION SET
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    1998-03-31

    (231 days)

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

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chase Medical Femoral Access Cannulation Set is intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician.
    Device Description
    Not Found
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    K Number
    K974568
    Device Name
    CHASE ANASTOMOSIS VISUALIZATION DEVICE
    Manufacturer
    CHASE MEDICAL, INC.
    Date Cleared
    1998-01-06

    (32 days)

    Product Code
    FQH, FMQ
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHASE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chase Anastomosis Visualization Device is indicated for use during procedures wherein clearing of a wound or surgical site, for enhanced visibility, must be maintained by non-contact means.
    Device Description
    The Chase Anastomosis Visualization Device consists of a malleable wand, a 0.2 micron filter, and a sterile fluid inlet line. The overall length of the wand is approximately 10.125 inches in length. The stainless steel wire is completely embedded within the wall along its length for the purpose of maintaining a user chosen shape. The distal tip is designed to provide a fan-shaped irreigation mist pattern. The remaining proximal length of the wand is the regulated gas inlet which consists of a 0.2 micron medical grade in-line bacterial filter made of a hydrophobic membrane and a 1/4 inch tubing connecter. A 1/4 inch PVC tube which connects the in-line filter to the regulated gas source. A fluid inlet line extends from a point near the proximal end of the malleable section of the wand and terminates in a female luer-lock adaptor for conneciton to a standard fluid administration set which provides for flow control and on-off capacity
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