FDA device listing
Elation5 Fixed Wire Balloon,Elation5 Wireguided Balloon,Elation Fixed Wire Balloon
FDA device listing 1710700357 · Terumo BCT, INC.
Key facts
| Proprietary names | Elation5 Fixed Wire Balloon,Elation5 Wireguided Balloon,Elation Fixed Wire Balloon |
|---|---|
| Owner/operator | Terumo BCT, INC. |
| Owner/operator number | 9002708 |
| Product codes | KNQ |
| Device names | KNQ - Dilator, Esophageal |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5365 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Terumo BCT STERILIZATION SERVICES, Inc. |
| Establishment registrations | 1724474 |
| FEI numbers | 3003094851 |
| Establishment operations | Contract Sterilizer |
| 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