DCB IAV09008008P 09.00 L080 UL0800 US

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