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510(k) Data Aggregation

    K Number
    K082191
    Device Name
    CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
    Manufacturer
    Date Cleared
    2008-08-19

    (15 days)

    Product Code
    Regulation Number
    870.2855
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOMEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.
    Device Description
    The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure s2 Wireless AAA Pressure Measurement System includes: - The CardioMEMS EndoSure™ s2 Sensor with radio-opaque markings -(implant) - A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ s2 Sensor) - CardioMEMS EndoSure™ Electronics System
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    K Number
    K070448
    Device Name
    CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
    Manufacturer
    Date Cleared
    2007-03-15

    (28 days)

    Product Code
    Regulation Number
    870.2855
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOMEMS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks. It also may be used for measuring intrasac pressure during thoracic aortic aneurysm (TAA) repair.
    Device Description
    The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System includes: - The CardioMEMS EndoSure™ Sensor with radio-opaque markings (implant) - A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure™ Sensor) - CardioMEMS EndoSure™ Electronics System
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    K Number
    DEN050006
    Device Name
    CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
    Manufacturer
    Date Cleared
    2005-10-28

    (80 days)

    Product Code
    Regulation Number
    870.2855
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOMEMS INC

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