| Device |
drug-coated peripheral transluminal angioplasty catheter |
| Definition |
Balloon dilatation of native and/or synthetic arteriovenous dialysis fistulae to establish or maintain patency |
| 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. |
| Technical Method |
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. |
| Target Area |
Synthetic and/or native arteriovenous dialysis fistulae. |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PRC |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
