Definition: Balloon Dilatation Of Native And/or Synthetic Arteriovenous Dialysis Fistulae To Establish Or Maintain Patency
| Device Type ID | 1085 |
| Device Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| 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 Si |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PRC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1085 |
| Device | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Product Code | PRC |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 26 |
Material Rupture | 7 |
Deflation Problem | 4 |
Material Split, Cut Or Torn | 2 |
Difficult To Remove | 2 |
Retraction Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Torn Material | 1 |
Device-Device Incompatibility | 1 |
| Total Device Problems | 45 |