| Device |
percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access |
| Regulation Description |
Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. |
| 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. |
| 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. |
| Technical Method |
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. |
| 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 Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PQK |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1252
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
