Identity
- Trade Name
- FLAIR ENDOVASCULAR STENT GRAFT FDA PMA
- Generic Name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment FDA PMA
Identifiers
- PMA Number
- P060002 FDA PMA
- FDA Product Code
- PFV FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Flair Endovascular Stent Graft is a Class III endovascular graft system designed for the treatment of stenoses at the venous anastomosis of expanded polytetrafluoroethylene (EPTFE) or other synthetic arteriovenous (AV) access grafts. It functions as a vascular prosthesis to restore blood flow in dialysis access circuits where narrowing has occurred.
This device is intended for use in interventional radiology or vascular surgery settings and is supplied in sterile, single-use configurations. It is approved under an FDA Premarket Approval (PMA) application (P060002) and is available in multiple reference codes for compatibility with various graft sizes. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to deployment.
Frequently asked questions
What clinical scenario is the Flair Endovascular Stent Graft specifically designed to address in dialysis patients?
The Flair Endovascular Stent Graft is designed to treat narrowing (stenoses) at the venous anastomosis—where an artificial graft connects to a vein—in expanded polytetrafluoroethylene (EPTFE) or other synthetic arteriovenous (AV) access grafts used for dialysis. It restores blood flow in these circuits when blockages occur, helping maintain effective dialysis access.
How is the Flair Endovascular Stent Graft supplied, and what does this mean for clinical workflow?
The Flair Endovascular Stent Graft is supplied in sterile, single-use configurations, meaning each device is pre-packaged for one-time deployment. This eliminates the need for reprocessing and ensures compliance with sterile medical device protocols, streamlining workflow in interventional radiology or vascular surgery settings.
Are there multiple sizes or models available for the Flair Endovascular Stent Graft, and how does this affect compatibility?
Yes, the Flair Endovascular Stent Graft is available in multiple reference codes, which correspond to different graft sizes. This allows clinicians to select the appropriate size for the patient’s specific AV access circuit, ensuring proper fit and functionality during deployment.
What regulatory pathway was followed for the approval of the Flair Endovascular Stent Graft, and what does this imply for its use?
The Flair Endovascular Stent Graft was approved under an FDA Premarket Approval (PMA) application (P060002), which is the highest level of regulatory review for Class III devices. This implies rigorous evaluation of safety and effectiveness before market authorization, ensuring it meets stringent standards for treating stenoses at venous anastomoses in AV dialysis access grafts.
What storage and handling requirements must be followed to maintain the integrity of the Flair Endovascular Stent Graft before use?
The Flair Endovascular Stent Graft must be stored and handled according to standard sterile medical device protocols to preserve its sterility and structural integrity. Since it is single-use, proper packaging and environmental controls are critical to prevent contamination before deployment in the clinical setting.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P060002 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bard Peripheral Vascular
Sources (1)
- FDA PMA P060002 24 fields · synced Sep 18, 2026