Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013611763

FEI Number

3013611763

Entity Name

Terumo Yamaguchi Corporation

City/State/Country

Yamaguchi-shi, JP

Establishment Address

3-22 Sayama-Aza-Murayama,, Yamaguchi-shi 754-0894, JP

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TERUMO CORP. (Owner Number: 8010026)

Owner / Operator Contact Address

44-1, 2-CHOME, HATAGAYA, --, SHIBUYA-KU, TOKYO, JP-NOTA 151-0072, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Radifocus Glidewire Advantage 014 Runthrough NS PTCA Guide Wire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-04-04
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Dina Justice Business: Terumo Medical Corp Email: dina.justice@terumomedical.com Phone: (410) 3927226

Related Public Records

Same Entity

TERUMO CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
9681839	Terumo Corporation Fujinomiya Factory	FUJINOMIYA-SHI Shizuoka, JP
3013874291	ME Center (Nagaizumi) of Terumo Corp	Sunto-gun, Shizuoka, JP
8010026	TERUMO CORP.	SHIBUYA-KU, TOKYO, JP
9681834	ASHITAKA FACTORY OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP

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
3024743081	EMBRACE MEDICAL LTD.	Tel Aviv, IL
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3018070217	SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD.	Suzhou Jiangsu, CN
3015522130	NANO4IMAGING USA, LLC.	Dublin, OH, US
3007635982	Confluent Medical Technologies, Inc	Fremont, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013611763. Last updated year: 2026. Please use registration number 3013611763 when referencing this establishment in official correspondence.