FDA device listing
Fluency Plus Endovascular Stent Graft
FDA device listing 1977743193 · C. R. Bard, Inc.
Key facts
| Proprietary names | Fluency Plus Endovascular Stent Graft |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Premarket submissions | P130029 |
| Product codes | PFV |
| Device names | PFV - System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.PFV |
| Review panels | Cardiovascular |
| Registered establishments | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG, Bard European Distribution Center NV, BARD PERIPHERAL VASCULAR, INC. |
| Establishment registrations | 2020394, 9681442, 3002504068 |
| FEI numbers | 2020394, 3002504068, 3002806368 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database