FDA device listing
Edwards EVOQUE Accessories,Edwards EVOQUE Stabilizer,Edwards Rail Tray,Edwards Reusable Accessories - Reusable…
FDA device listing 1591930772 · Edwards Lifesciences LLC
Key facts
| Proprietary names | Edwards EVOQUE Accessories,Edwards EVOQUE Stabilizer,Edwards Rail Tray,Edwards Reusable Accessories - Reusable Cradle,Edwards Reusable Accessories - Reusable Plate,Edwards Reusable Accessories - Reusable Platform,Edwards Reusable Rail,Edwards Reusable Rail Extension,Edwards Stabilizer Rail System,Edwards Stabilizer Set,PASCAL System - Stabilizer Rail System,PASCAL System - Table,SAPIEN M3… |
|---|---|
| Owner/operator | Edwards Lifesciences LLC |
| Owner/operator number | 9040666 |
| Product codes | QWA |
| Device names | QWA - Cardiovascular Delivery Catheter System Positioning And Stabilization Device |
| Device class | Class I |
| Classification regulations (21 CFR) | 870.3955 |
| Review panels | Cardiovascular |
| Registered establishments | Edwards Lifesciences Ireland Limited, Edwards Lifesciences LLC, EDWARDS LIFESCIENCES LLC, Edwards Lifesciences LTD |
| Establishment registrations | 2015691, 3008500478, 3015179394, 3017298588 |
| FEI numbers | 1713910, 2015691, 3015179394, 3017298588 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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