FDA device listing
nSTRIDE APS Kit (800-3000ST), APS Kit (800-3000JP)
FDA device listing 1192605984 · Advanced Engineering, Inc.
Key facts
| Proprietary names | nSTRIDE APS Kit (800-3000ST), APS Kit (800-3000JP) |
|---|---|
| Owner/operator | Advanced Engineering, Inc. |
| Owner/operator number | 10042897 |
| Product codes | PZT |
| Device names | PZT - Peripheral Blood Processing Device For Osteoarthritis |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.PZT |
| Review panels | Hematology |
| Registered establishments | ADVANCED ENGINEERING, INC. |
| Establishment registrations | 3010047203 |
| FEI numbers | 3010047203 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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