NC TREK Coronary Dilatation Catheter 4.5 mm x 12 mm / Rapid-Exchange


Product Overview

NC TREK Coronary Dilatation Catheter 4.5 mm x 12 mm / Rapid
NC TREK - 1012454-12


Device Description

A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store in a dry, dark, cool place

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LOX

    Device Name: Catheters, Transluminal Coronary Angioplasty, Percutaneous

    Device Class: 2

    Physical State: N/A

    Definition: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

    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: 870.5100

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 08717648152108

    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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