Ultraverse® RX PTA Dilatation Catheter 4 mm x 80 mm, 200 cm Catheter


Product Overview

Ultraverse® RX PTA Dilatation Catheter 4 mm x 80 mm, 200 cm Catheter
Ultraverse® RX - U420048RX


Device Description

A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Balloon diameter, 4 Millimeters
  • Catheter shaft length, 200 Centimeters
  • Balloon length, 80 Millimeters
    • Balloon diameter, 4 Millimeters
    • Catheter shaft length, 200 Centimeters
    • Balloon length, 80 Millimeters


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LIT

    Device Name: Catheter, Angioplasty, Peripheral, Transluminal

    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: 870.1250

    Third Party Flag: Y

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00801741057533

    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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