Identity
- Trade Name
- Covera Vascular Covered Stent FDA PMA
- Generic Name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment FDA PMA
Identifiers
- PMA Number
- P170042 FDA PMA
- FDA Product Code
- PFV FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Covera Vascular Covered Stent is an endovascular graft system designed for the treatment of stenoses in arteriovenous (AV) dialysis access circuits. It is specifically indicated for use in the venous anastomosis of ePTFE and other synthetic arterio-venous access grafts.
Supplied by C. R. Bard, Inc., this device is a Class III medical device authorized under FDA PMA P170042. It is intended for endovascular use in dialysis access circuit stenosis treatment and is not described as sterile, single-use, or reusable in the provided data.
Frequently asked questions
What is the Covera Vascular Covered Stent used for?
The Covera Vascular Covered Stent is indicated for the treatment of stenoses at the venous anastomosis of ePTFE and other synthetic arterio-venous (AV) access grafts, as stated in the approval documentation.
Who manufactures the Covera Vascular Covered Stent?
The Covera Vascular Covered Stent is manufactured by C. R. Bard, Inc., located in Tempe, Arizona, as indicated in the applicant and address fields.
What regulatory authorization covers the Covera Vascular Covered Stent?
The device is authorized under FDA Premarket Approval (PMA) with number P170042, as shown in the AUTHORIZATIONS and pma_number fields.
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 | P170042 | Class III | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA PMA P170042 24 fields · synced Sep 18, 2026