Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002244583

FEI Number

3002244583

Entity Name

TORAY MEDICAL CO., LTD.

City/State/Country

Chuo-ku Tokyo, JP

Establishment Address

19-21, Nihonbashi-Hakozakicho, Chuo-ku Tokyo 103-0015, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

TORAY MEDICAL CO., LTD. (Owner Number: 9088449)

Owner / Operator Contact Address

19-21, Nihonbashi-Hakozakicho, Chuo-ku, JP-13 103-0015, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P910054

All Registered Proprietary Names

XR-700 TORAYGUIDE GUIDEWIRE INOUE BALLOON CATHETER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2009-11-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2006-06-12
MAD	Catheter, Percutaneous (Valvuloplasty)	Unknown	Class 3	N/A	2006-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

YUYA SHIZUME Business: Toray Industries (America), Inc. Email: yuya.shizume.a2@mail.toray Phone: (212) 6978150

Related Public Records

Same Entity

TORAY MEDICAL CO., LTD.

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.

Similar Registrations

Registration Number	Establishment Name	Location
3032848578	Burlington Medical LLC	Newport News, VA, US
3040389667	CANGZHOU JINKUIJIA MEDICAL DEVICES CO., LTD.	Cangzhou Hebei, CN
1835044	LT ACQUISITION, INC.	Caledonia, MI, US
1222742	BURLINGTON MEDICAL, LLC	Newport News, VA, US
3013463240	HUANGHUA DK DENTAL CO., LTD	HuangHua Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002244583. Last updated year: 2026. Please use registration number 3002244583 when referencing this establishment in official correspondence.