WavelinQ™ 4F EndoAVF System

WavelinQ™ 4F EndoAVF System
WavelinQ - W04200

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

No Data Available

• Arterial Catheter Length, 50 Centimeters
• Catheter Gauge: 4 French
• Venous Catheter Length, 43 Centimeters

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PQK

Device Name: Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Device Class: 2

Physical State: The percutaneous catheter is generally constructed of synthetic materials such as plastic and introduced into the body using a guidewire. The catheter may be manufactured in multiple sizes to allow for the creation of a fistula in vessels of different sizes. The catheter may or may not be connected to a power source to deliver energy to the site of fistula creation. The catheter may incorporate additional technology to facilitate the alignment and connection between the artery and the vein.

Definition: Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The catheter creates an arteriovenous fistula (AVF), which is a physical connection between an artery and an adjacent vein, by mechanical means or by delivering energy such as heat or radiofrequency (RF) energy. The fistula allows high-pressure blood from the artery to flow into the vein, which increases the size of the vein and allows needle access for hemodialysis.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Arteriovenous fistulas created in the blood vessels of the arm. These may include radiocephalic, brachiocephalic, brachiobasilic, and ulnar artery-ulnar vein fistulas.

Regulation Number: 870.1252

Third Party Flag: N

Medical Specialty: CV

Device Id: 00801741182754

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