FDA device listing
Next Generation Balloon Dilation System
FDA device listing 1511213532 · Confluent Medical Technologies, Inc.
Key facts
| Proprietary names | Next Generation Balloon Dilation System |
|---|---|
| Owner/operator | Confluent Medical Technologies, Inc. |
| Owner/operator number | 10033958 |
| Product codes | LRC, PGW, PNZ |
| Device names | LRC - Instrument, Ent Manual Surgical, PGW - Ear, Nose, And Throat Stereotaxic Instrument, PNZ - Eustachian Tube Balloon Dilation Device |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 874.4180, 874.4420, 882.4560 |
| Review panels | Ear, Nose, & Throat, Neurology |
| Registered establishments | Nitinol Devices & Components Costa Rica, S. R. L. |
| Establishment registrations | 3009018440 |
| FEI numbers | 3009018440 |
| Establishment operations | Contract Manufacturer |
| 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