Data / Medical devices / Japan / Terumo Clinical Supply Co., Ltd.
Terumo Clinical Supply Co., Ltd.: FDA-registered device maker in Kakamigahara Gifu, Japan, 2 510(k) clearances
Terumo Clinical Supply Co., Ltd. is registered with the FDA (registration 3009500972) in Kakamigahara Gifu, Japan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 21, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009500972
- Address
- 3 Kawashima-Takehaya-machi, Kakamigahara Gifu, Japan, 501-6024
- Owner or operator
- Terumo Clinical Supply Co., Ltd. (10039657)
- Roles
- Manufacturer
- First device listed
- January 31, 2012
- Registered through
- 2026
- Brand names listed
- Progreat Lambda, Progreat Lambda Peripheral Microcatheter, Terumo PriorityOne AC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aspiration Thrombectomy Catheter | QEZ | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | 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 |
|---|---|---|---|---|---|---|
| December 21, 2021 | K211078 | Progreat Lambda | DQO | Substantially Equivalent | Terumo Clinical Supply Co., Ltd. | accessdata.fda.gov |
| December 14, 2011 | K112382 | TERUMO ASPRIATION CATHETER | QEZ | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Aspiration Thrombectomy Catheter
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Continuous Flush
Updated December 21, 2021. 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.