FDA device listing
HydroFill (Formerly HydroSoft Plus)
FDA device listing 2038930360 · MicroVention Inc.
Key facts
| Proprietary names | HydroFill (Formerly HydroSoft Plus) |
|---|---|
| Owner/operator | MicroVention Inc. |
| Owner/operator number | 10033879 |
| Premarket submissions | K112226 |
| Product codes | HCG |
| Device names | HCG - Device, Neurovascular Embolization |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5950 |
| Review panels | Neurology |
| Registered establishments | MicroVention Costa Rica S.R.L., MicroVention, Inc. |
| Establishment registrations | 3010079067, 3013556777 |
| FEI numbers | 3010079067, 3013556777 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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