FDA device listing
Duralon Occl. Balloon, 3 lumen
FDA device listing 1983149596 · SHENT USA, INC.
Key facts
| Proprietary names | Duralon Occl. Balloon, 3 lumen |
|---|---|
| Owner/operator | SHENT USA, INC. |
| Owner/operator number | 10078923 |
| Premarket submissions | K013737 |
| Product codes | FGE |
| Device names | FGE - Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5010 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | TeleMed Systems |
| Establishment registrations | 1222168 |
| FEI numbers | 1222168 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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