FDA device listing
Surpass Elite Flow Diverter System,Surpass Evolve Flow Diverter,Surpass Streamline Flow Diverter
FDA device listing 1109464444 · STRYKER CORP.
Key facts
| Proprietary names | Surpass Elite Flow Diverter System,Surpass Evolve Flow Diverter,Surpass Streamline Flow Diverter |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | P170024 |
| Product codes | OUT |
| Device names | OUT - Intracranial Aneurysm Flow Diverter |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OUT |
| Review panels | Neurology |
| Registered establishments | STRYKER EMEA Supply Chain Services, Stryker Neurovascular |
| Establishment registrations | 3008837339, 3008853977, 3008881809 |
| FEI numbers | 3008837339, 3008853977, 3008881809 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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