Toray Industries (America), Inc.
Bellaire, TX, US
Toray Industries (America), Inc. appears in FDA device records in Bellaire, TX. FDA records list 18 510(k) clearances between and , 13 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 13
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Toray Industries (America), Inc. between 1986 and 2004. The busiest year on record is 1986, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 3 |
| 1995 | 3 |
| 2000 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042370 | TORAYGUIDE GUIDEWIRE | DQX | Substantially Equivalent | |
| K030050 | TORAYSULFONE DIALYZER, BS-L SERIES | KDI | Substantially Equivalent | |
| K002512 | TORAYSULFONE DIALYZER | KDI | Substantially Equivalent | |
| K994198 | HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L | KDI | Substantially Equivalent | |
| K942681 | FILTRYZER | KDI | Substantially Equivalent | |
| K935471 | FILTRYZER(TM) | FJI | Substantially Equivalent | |
| K940910 | FILTRYZER | FJI | Substantially Equivalent | |
| K884339 | TORAY FILTRYZER DIALYZERS | FJI | Substantially Equivalent | |
| K883407 | TORAY FILTRYZER BK SERIES | KDI | Substantially Equivalent | |
| K884083 | TORAY VASCULAR PROSTHESIS | DSY | Substantially Equivalent | |
| K882158 | MODIFIED TORAY FILTRYZER DIALYZERS | FJI | Substantially Equivalent | |
| K881236 | TORAY ANTHRON P-U CATHETERS | FOZ | Substantially Equivalent | |
| K874542 | TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES | DQX | Substantially Equivalent | |
| K872983 | TORAY ANTHRON ANGIOGRAPHIC CATHETERS | DQR | Substantially Equivalent | |
| K872762 | TORAY ANTHRON AORTA BYPASS TUBES | DWF | Substantially Equivalent | |
| K861115 | TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE | DQX | Substantially Equivalent | |
| K861117 | ANTHRON CATHETERS & SETS | FOZ | Substantially Equivalent | |
| K861116 | TORAY ANTHRON BYPASS TUBES | DWF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DQRCannula, Catheter
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- MADCatheter, Percutaneous (Valvuloplasty)
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- LPMLenses, Soft Contact, Extended Wear
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain