Data / Medical devices / Thailand / Asahi Intecc (thailand) Co., Ltd.
Asahi Intecc (thailand) Co., Ltd.: FDA-registered device maker in Amphur Muang Pathumthani Pathum Thani, Thailand, 1 510(k) clearance
Asahi Intecc (thailand) Co., Ltd. is registered with the FDA (registration 3003780911) in Amphur Muang Pathumthani Pathum Thani, Thailand. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 8, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003780911
- Address
- 158/1 Moo 5, Bangkadi Idustrial Park TIWANON ROAD, TAMBOL BANGKADI, Amphur Muang Pathumthani Pathum Thani, Thailand, 12000
- Owner or operator
- ASAHI INTECC CO., LTD. (9051916)
- Roles
- Contract manufacturer, Specification developer
- First device listed
- January 3, 2006
- Registered through
- 2026
- Brand names listed
- ASAHI CHIKAI black 14 soft tip, ASAHI CONFIANZA PRO 12 180cm, ASAHI CONFIANZA PRO 12 300cm, ASAHI CONFIANZA PRO 180cm, ASAHI CONFIANZA PRO 300cm, ASAHI Caravel, ASAHI Corsair Armet 135cm, ASAHI Corsair Armet 150cm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Peripheral, Atherectomy | MCW | 2 | Contract manufacturer | accessdata.fda.gov |
| Electrode, Electrosurgical, Active, Urological | FAS | 2 | Contract manufacturer | accessdata.fda.gov |
| Guide, Wire, Catheter, Neurovasculature | MOF | 2 | Contract manufacturer | accessdata.fda.gov |
| Snare, Flexible | FDI | 2 | Contract manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2020 | K202252 | ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), | DQY | Substantially Equivalent | Asahi Intecc Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Guide, Catheter
- All makers of Catheter, Percutaneous, Neurovasculature
- All makers of Catheter, Percutaneous
- All makers of Catheter, Peripheral, Atherectomy
- All makers of Guide, Wire, Catheter, Neurovasculature
- All makers of Electrode, Electrosurgical, Active, Urological
Updated September 8, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.