Fluency Plus Endovascular Stent Graft
by Bard Peripheral Vascular, Inc. PMA
Active
PMA P130029
Overview
The Fluency Plus Endovascular Stent Graft is a System, Endovascular Graft, Arteriovenous (AV) Dialysis Access Circuit Stenosis Treatment, classified as a Class III medical device. It is designed to treat in-stent restenosis in the venous outflow of hemodialysis patients, including those dialyzing via arteriovenous (AV) fistulas or grafts. This device is intended for endovascular placement to restore and maintain vascular patency in dialysis access circuits.
The Fluency Plus Endovascular Stent Graft is supplied in multiple sizes and configurations, as indicated by its FEI numbers (e.g., 3015225571, 3002806368). It has received FDA_PMA approval under PMA number P130029, with regulatory filing under product code PFV. The device is intended for single-use in controlled clinical settings, though sterility and MRI safety specifications are not explicitly detailed in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP130029 | Date17 Jun 2014 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- PMA Number
- FDA Product Code
- PFV
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Other devices from Bard Peripheral Vascular, Inc.
Questions
What specific vascular issue does the Fluency Plus Endovascular Stent Graft address in hemodialysis patients?
The Fluency Plus Endovascular Stent Graft is designed to treat **in-stent restenosis**—the narrowing or blockage that can recur within a previously placed stent—in the **venous outflow** of hemodialysis circuits. This includes patients using arteriovenous (AV) fistulas or grafts, where maintaining vascular patency is critical for effective dialysis.
How is the Fluency Plus Endovascular Stent Graft supplied, and what size options are available?
The device is supplied in multiple configurations, each identified by unique FEI numbers (e.g., 3015225571, 3002806368). These numbers correspond to specific sizes and designs tailored for endovascular placement in venous outflow stenosis. The exact dimensions or sizing details are not provided in the data, but the variety of FEI numbers suggests options to accommodate different patient anatomies.
Is the Fluency Plus Endovascular Stent Graft intended for reuse, or is it single-use?
The Fluency Plus Endovascular Stent Graft is **intended for single-use** in controlled clinical settings, as explicitly stated in the device description. This aligns with standard practices for endovascular implants to ensure patient safety and sterility.
What regulatory pathway was followed for FDA approval of this device?
The Fluency Plus Endovascular Stent Graft received **FDA_PMA approval** under PMA number **P130029**, filed under product code **PFV**. This pathway is reserved for Class III devices, which require a Premarket Approval (PMA) application to demonstrate safety and effectiveness. The approval was granted on June 17, 2014, following review by the FDA’s Cardiovascular (CV) advisory committee.