DCB IAV08006013P 08.00 L060 UL1300 US

DCB IAV08006013P 08.00 L060 UL1300 US
IN.PACT™ AV - IAV08006013P

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.

• Outer Diameter: 8.0 Millimeter
• Length: 60.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00763000233174

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