DCB IAV09008008P 09.00 L080 UL0800 US


Product Overview

DCB IAV09008008P 09.00 L080 UL0800 US
IN.PACT™ AV - IAV09008008P


Device Description

A sterile, 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, and to simultaneously release a drug intended to inhibit restenosis; 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. This is a single-use device.


Environmental Conditions

  • Special Storage Condition, Specify
    • Store the device in the original container. Do not store near radiation or ultraviolet light sources.
  • Special Storage Condition, Specify
    • Keep Away from Sunlight
  • Special Storage Condition, Specify
    • Keep Dry
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00

  • Device Sizes

  • Length: 80.0 Millimeter
  • Outer Diameter: 9.0 Millimeter
    • Length: 80.0 Millimeter
    • Outer Diameter: 9.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PRC

    Device Name: Drug-Coated Peripheral Transluminal Angioplasty Catheter

    Device Class: 3

    Physical State: The balloon catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire. The balloon is generally manufactured in multiple diameters and lengths to allow for treatment of different lesion sizes. There is typically a drug coating on the balloon with assists in maintaining vessel patency.

    Definition: Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency

    Submission Type ID: 2

    Review Panel: CV

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: The balloon catheter uses mechanical force across a lesion to establish patency. The drug coating serves as an adjunct to the mechanical action of balloon angioplasty and assists in maintaining vessel patency post-procedure.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Synthetic and/or native arteriovenous dialysis fistulae.

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00763000232696

    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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