Linear 7.5Fr. 40cc IAB (China)


Product Overview

Linear 7.5Fr. 40cc IAB (China)
Linear 7.5Fr. 40cc IAB (China) - 0684-00-0480-01C


Device Description

A flexible, balloon-tipped, tube that is placed in the aorta distal to the aortic valve to augment the heart's pumping capability. It is typically introduced percutaneously via one of the femoral arteries and advanced to the descending thoracic aorta using fluoroscopic imaging guidance. Once positioned, an external pump alternately inflates and deflates the balloon in a cycle counter to the cardiac cycle (counter pulsation), facilitating ejection during systole and limits regurgitation during diastole. It is used to treat several cardiovascular conditions, e.g., after open-heart surgery, cardiogenic shock, intractable angina, or to reduce myocardial conditions. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Catheter Gauge: 7.5 French
    • Catheter Gauge: 7.5 French


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Ethylene Oxide
    • Ethylene Oxide


    Product Codes

    Code: DSP

    Device Name: System, Balloon, Intra-Aortic And Control

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 870.3535

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 10607567109343

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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