Data / Medical devices / Japan / Toray Industries, Inc. Seta Plant
Toray Industries, Inc. Seta Plant: FDA-registered device maker in OTSU Shiga, Japan, 2 510(k) clearances and 1 PMA approval
Toray Industries, Inc. Seta Plant is registered with the FDA (registration 9612812) in OTSU Shiga, Japan. It lists 3 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated December 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612812
- FEI number
- 3002808331
- Address
- 1-1, Oe 1-Chome, OTSU Shiga, Japan, 520-2141
- Owner or operator
- TORAY INDUSTRIES, INC. SETA PLANT (9021655)
- Roles
- Manufacturer
- First device listed
- July 19, 2002
- Registered through
- 2026
- Brand names listed
- INOUE BALLOON A, INOUE BALLOON CATHETER, TORAYGUIDE GUIDEWIRE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous (Valvuloplasty) | MAD | 3 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 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 18, 2022 | K220881 | INOUE BALLOON A | OZT | Substantially Equivalent | Toray Industries, Inc. | accessdata.fda.gov |
| December 17, 2004 | K042370 | TORAYGUIDE GUIDEWIRE | DQX | Substantially Equivalent | Toray Industries (America), Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 28, 1994 | P910054 | INOUE BALLOON CATHETER | MAD | 9 | July 1, 2024 | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous (Valvuloplasty)
- All makers of Wire, Guide, Catheter
- All makers of Balloon Aortic Valvuloplasty
Updated July 1, 2024. 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.