Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614758

FEI Number

3002710305

Entity Name

TORAY INDUSTRIES, INC.

City/State/Country

CHUO-KU Tokyo, JP

Establishment Address

1-1, NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU Tokyo 103-8666, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TORAY INDUSTRIES, INC. (Owner Number: 9037937)

Owner / Operator Contact Address

1-1, NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, JP-13 103-8666, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220881

PMA Number

N/A

All Registered Proprietary Names

Inoue Balloon Catheter INOUE BALLOON A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAD	Catheter, Percutaneous (Valvuloplasty)	Unknown	Class 3	N/A	2007-12-05
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2023-02-09

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 INDUSTRIES, INC.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
9612812	TORAY INDUSTRIES, INC. SETA PLANT	OTSU Shiga, JP
3002244583	TORAY MEDICAL CO., LTD.	Chuo-ku Tokyo, JP
1318694	NUMED, INC.	Hopkinton, NY, US
1649869	TORAY INTERNATIONAL AMERICA INC.	HOUSTON, TX, US
1018233	C.R. BARD, INC.	COVINGTON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614758. Last updated year: 2026. Please use registration number 9614758 when referencing this establishment in official correspondence.