LogoFDA 510(k) Search
Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

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

    (15 days)

    Product Code
    NQH
    Regulation Number
    870.2855
    Why did this record match?
    Product Code :

    NQH

    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
    Ask a Question

    Ask a specific question about this device

    K Number
    K070680
    Device Name
    CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080
    Manufacturer
    CARDIOMEMS, INC.
    Date Cleared
    2007-04-05

    (24 days)

    Product Code
    NQH
    Regulation Number
    870.2855
    Why did this record match?
    Product Code :

    NQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioMEMS EndoSure™ s2 14F 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.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K070448
    Device Name
    CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
    Manufacturer
    CARDIOMEMS INC
    Date Cleared
    2007-03-15

    (28 days)

    Product Code
    NQH
    Regulation Number
    870.2855
    Why did this record match?
    Product Code :

    NQH

    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
    Ask a Question

    Ask a specific question about this device

    K Number
    K061046
    Device Name
    CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001
    Manufacturer
    CARDIOMEMS, INC.
    Date Cleared
    2006-10-12

    (181 days)

    Product Code
    NQHNOH
    Regulation Number
    870.2855
    Why did this record match?
    Product Code :

    NQH

    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. It may be used as an adjunctive tool in the detection of intraoperative endoleaks.
    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 Interrogator
    Ask a Question

    Ask a specific question about this device

    K Number
    DEN050006
    Device Name
    CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
    Manufacturer
    CARDIOMEMS INC
    Date Cleared
    2005-10-28

    (80 days)

    Product Code
    NQH
    Regulation Number
    870.2855
    Why did this record match?
    Product Code :

    NQH

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

    Ask a specific question about this device

    Page 1 of 1