Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009092139

FEI Number

3009092139

Entity Name

Yokowo Co., Ltd

City/State/Country

Tomioka Gunma, JP

Establishment Address

1112 Kanohara, Tomioka Gunma 370-2495, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Yokowo Co., Ltd. (Owner Number: 10047481)

Owner / Operator Contact Address

5-11 Takinogawa, 7-Chome, Kita-ku, JP-13 114-8515, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Traxcess 14 SELECT Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-07-29
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2022-02-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-11-11
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2021-11-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-01-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-11-11
MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	Class 2	870.1330	2021-11-11

Official Correspondent

Koichi Tachikawa

US Agent Details

Isao Tokuda Email: is-tokuda@jp.yokowo.com Phone: (602) 8888331

Related Public Records

Same Entity

Yokowo 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.
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.

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 3009092139. Last updated year: 2026. Please use registration number 3009092139 when referencing this establishment in official correspondence.