FDA device listing
Coaxial Introducer
FDA device listing 1931313446 · ARGON MEDICAL DEVICES, INC
Key facts
| Proprietary names | Coaxial Introducer |
|---|---|
| Owner/operator | ARGON MEDICAL DEVICES, INC |
| Owner/operator number | 9059795 |
| Premarket submissions | K940024 |
| Product codes | GAA |
| Device names | GAA - Needle, Aspiration And Injection, Disposable |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | ARGON MEDICAL DEVICES, INC. |
| Establishment registrations | 1417485 |
| FEI numbers | 1417485 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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