Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB


Product Overview

Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB
Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB - 0884-00-0019-12


Device Description

A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. 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: 10607567106632

    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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