ULTRASCORE™ Focused Force PTA Balloon 7mm x 40mm, 130cm catheter


Product Overview

ULTRASCORE™ Focused Force PTA Balloon 7mm x 40mm, 130cm catheter
ULTRASCORE - US3513074


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 Length, 40 Millimeter
  • Balloon Diameter, 7 Millimeter
  • Shaft Length, 130 Centimeter
    • Balloon Length, 40 Millimeter
    • Balloon Diameter, 7 Millimeter
    • Shaft Length, 130 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PNO

    Device Name: Catheter, Percutaneous, Cutting/Scoring

    Device Class: 2

    Physical State: Cutting/scoring catheters are usually comprised of flexible polymers for the catheter body and a compliant polymer for the balloon. The cutting/scoring elements are usually metal.

    Definition: To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

    Submission Type ID: 1

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The device is typically placed using a guidewire and guiding catheter. The active end is typically expanded and the cutting/scoring surfaces are apposed to the vessel wall to cause cracking or breaking of the stenosis.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Peripheral arteries and arteriovenous dialysis fistulae

    Regulation Number: 870.1250

    Third Party Flag: N

    Medical Specialty: CV


    Device Identifiers

    Device Id: 00801741116940

    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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