FDA device listing
Drug-Eluting Peripheral Transluminal Angioplasty Catheter
FDA device listing 1244891952 · Synergy Health AST, LLC
Key facts
| Owner/operator | Synergy Health AST, LLC |
|---|---|
| Owner/operator number | 10028672 |
| Product codes | ONU |
| Device names | ONU - Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.ONU |
| Review panels | Cardiovascular |
| Registered establishments | Synergy Health AST, LLC |
| Establishment registrations | 2030598, 3012102437 |
| FEI numbers | 1000518731, 3012102437 |
| 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