FDA device listing
ASAHI Gaia First,ASAHI Gaia PV18,ASAHI Gaia Second,ASAHI Gaia Third,ASAHI Gladius18,ASAHI SION,ASAHI SION blue,Astato…
FDA device listing 1194076658 · ASAHI INTECC CO., LTD.
Key facts
| Proprietary names | ASAHI Gaia First,ASAHI Gaia PV18,ASAHI Gaia Second,ASAHI Gaia Third,ASAHI Gladius18,ASAHI SION,ASAHI SION blue,Astato 30,Astato XS 20,Astato XS40,CONFIANZA PRO,CONFIANZA PRO 12,EXTENSION,FIELDER,FIELDER FC,FIELDER XT,FIELDER XT-A,FIELDER XT-R,GRAND SLAM,Halberd18,MIRACLEBROS 12,MIRACLEBROS 3,MIRACLEBROS 6,PROWATER,PROWATERflex,Regalia XS 1.0,SOFT,Treasure 12,Treasure Floppy,ULTIMATEbros 3 |
|---|---|
| Owner/operator | ASAHI INTECC CO., LTD. |
| Owner/operator number | 9051916 |
| Premarket submissions | K163426 |
| Product codes | DQX, MOF |
| Device names | DQX - Wire, Guide, Catheter, MOF - Guide, Wire, Catheter, Neurovasculature |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.1330 |
| Review panels | Cardiovascular |
| Registered establishments | ASAHI INTECC CO., LTD., ASAHI INTECC HANOI CO., LTD., ASAHI INTECC (THAILAND) CO., LTD., Toyoflex Cebu Corporation |
| Establishment registrations | 3003775027, 3003780911, 3009121749, 3016119728 |
| FEI numbers | 3003775027, 3003780911, 3009121749, 3016119728 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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