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 Hemodia
| Device Type ID | 979 |
| Device Name | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| 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 Differen |
| 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 |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1252 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 979 |
| Device | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Product Code | PQK |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 870.1252 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
Failure To Cut | 1 |
| Total Device Problems | 4 |