PFV · System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
· Class 3
Overview
| Product Code | PFV |
|---|---|
| Device Name | System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240023 | WRAPSODY® Cell-Impermeable Endoprosthesis | Merit Medical Systems, Inc. | Dec 19, 2024 | APPR |
| P170042 | Covera Vascular Covered Stent | C.R. Bard, Inc. | Jul 30, 2018 | APPR |
| P130029 | FLUENCY PLUS ENDOVASCULAR STENT GRAFT | Bard Peripheral Vascular, Inc. | Jun 17, 2014 | APPR |
| P130006 | GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE | W. L. Gore & Associates, Inc. | Dec 5, 2013 | APPR |
| P060002 | FLAIR ENDOVASCULAR STENT GRAFT | Bard Peripheral Vascular | Jul 23, 2007 | APWD |
Top Applicants
- Bard Peripheral Vascular — 1 clearance
- Bard Peripheral Vascular, Inc. — 1 clearance
- C.R. Bard, Inc. — 1 clearance
- Merit Medical Systems, Inc. — 1 clearance
- W. L. Gore & Associates, Inc. — 1 clearance
