Data / Medical devices / United States / Toray International America Inc.
Toray International America Inc.: FDA-registered device maker in Houston, TX, United States, 2 510(k) clearances and 1 PMA approval
Toray International America Inc. is registered with the FDA (registration 1649869) in Houston, TX, United States. It lists 4 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated December 18, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1649869
- FEI number
- 3001632632
- Address
- 140 Cypress Station DR. Suite 210, Houston, TX, United States, 77090
- Owner or operator
- TORAY INTERNATIONAL AMERICA INC. (2435106)
- Roles
- Complaint file establishment
- First device listed
- November 14, 2007
- Registered through
- 2026
- Brand names listed
- INOUE BALLOON A, Inoue Balloon catheter, Torayguide Guidewire, XR-700
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Percutaneous (Valvuloplasty) | MAD | 3 | Complaint file establishment | accessdata.fda.gov |
| Shield, Eye, Radiological | IWS | 1 | Complaint file establishment | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Complaint file establishment | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 30, 2003 | 28027 | Not yet classified | Terminated | Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H | Potential loose header (end cap) on hollow fiber dialyzers. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous (Valvuloplasty)
- All makers of Shield, Eye, Radiological
- All makers of Balloon Aortic Valvuloplasty
- All makers of Wire, Guide, Catheter
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.