Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1649869

FEI Number

3001632632

Entity Name

TORAY INTERNATIONAL AMERICA INC.

City/State/Country

HOUSTON, TX, US

Establishment Address

140 CYPRESS STATION DR., SUITE 210, HOUSTON, TX 77090, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

TORAY INTERNATIONAL AMERICA INC. (Owner Number: 2435106)

Owner / Operator Contact Address

140 CYPRESS STATION DR., SUITE 210, Houston, TX 77090, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042370

PMA Number

N/A

All Registered Proprietary Names

INOUE BALLOON A XR-700 Inoue Balloon catheter Torayguide Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2023-02-09
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2015-03-03
MAD	Catheter, Percutaneous (Valvuloplasty)	Unknown	Class 3	N/A	2007-11-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TORAY INTERNATIONAL AMERICA INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

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2011171	Sterigenics US LLC	Los Angeles, CA, US
1313046	C.R. BARD, INC.	Queensbury, NY, US
3029663075	Medinotec Inc	Dix Hills, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649869. Last updated year: 2026. Please use registration number 1649869 when referencing this establishment in official correspondence.