FDA device listing
07-932-02 Sugita AVM Microclip 2mm,07-932-03 Sugita AVM Microclip 3mm,07-932-04 Sugita AVM Microclip 4mm,07-932-05…
FDA device listing 1091159455 · MIZUHO Corporation
Key facts
| Proprietary names | 07-932-02 Sugita AVM Microclip 2mm,07-932-03 Sugita AVM Microclip 3mm,07-932-04 Sugita AVM Microclip 4mm,07-932-05 Sugita AVM Microclip 5mm,07-935-10 Sugita AVM Micro Clip Applier,07-935-20 Sugita AVM Micro Clip Applier,07-935-22-MA Sugita AVM Microclip Applier short,07-935-42 Sugita AVM Micro Clip Single Shaft Applier 90mm, Str, w/o Catches,07-935-43 Sugita AVM Micro Clip Single Shaft Applier… |
|---|---|
| Owner/operator | MIZUHO Corporation |
| Owner/operator number | 9007414 |
| Premarket submissions | K960037 |
| Product codes | HCH |
| Device names | HCH - Clip, Aneurysm |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5200 |
| Review panels | Neurology |
| Registered establishments | MIZUHO CORPORATION, MIZUHO Corporation Gosen Factory |
| Establishment registrations | 9680242, 3011547624 |
| FEI numbers | 3009504761, 3011547624 |
| Establishment operations | Foreign Exporter, 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