Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681834

FEI Number

3002808327

Entity Name

ASHITAKA FACTORY OF TERUMO CORP.

City/State/Country

FUJINOMIYA Shizuoka, JP

Establishment Address

150 MAIMAIGI-CHO, FUJINOMIYA Shizuoka 418-0015, JP

Establishment Type(s)

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

R2P Radifocus Glidewire Advantage CAPIOX® AF125X Arterial Filter CAPIOX Bubble Trap Guide Wire M and Tapered Glidewire Gold Radifocus Guide Wire CAPIOX SP Pump (With or Without X-Coating) R2P SlenGuide Radifocus Glidewire Advantage 014 CHAPERON GUIDING CATHETER NaviCross 018" Runthrough NS Extension Wire CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir MISAGO RX Self-expanding Peripheral Stent Radifocus Glidecath Hydrophilic Coated Catheter Radifocus Torque Device TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir Glidewire Gold Neuro Neuro Glidewires Headliner Hydrophilic Coated Guidewire Finecross MG Coronary Micro-Guide Catheter Obturator Glidesheath CAPIOX FX15 and FX25 Hollow Fiber Oxygenator/Reservoir with Integrated Arterial Filter (with X-Coating) Heartrail III 5Fr Guiding Catheter Heartrail III Coronary Guiding Catheter Radifocus Glidewire CAPIOX Arterial Filter Terumo Hollow Fiber Oxygenator Circuit Runthrough NS PTCA Guide Wire TRAXCESS 014" HYDROPHILIC GUIDEWIRE CAPIOX® RX15 Hollow Fiber Oxygenator w/without Hardshell Reservoir CAPIOX SP Pump Head Radifocus Optitorque Angiographic Catheter Progreat Progreat Coaxial Microcatheter System Terumo NaviCross Support Catheter Radifocus Glidewire Advantage TRAXCESS DOCKING 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	2025-04-02
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2007-11-30
KRL	Detector, Bubble, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4205	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2015-04-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-12-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-04-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-12-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-04-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-03-24
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2007-11-30
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2015-05-27
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-12-18
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2008-10-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2008-10-06
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2013-03-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-07-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2009-09-15
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-11-17
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2007-11-30
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-05-05
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2007-11-30
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2015-04-24
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-11-30
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-11-30
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-05-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-03-01

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
3013611763	Terumo Yamaguchi Corporation	Yamaguchi-shi, 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

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-0024-2011	Terumo Cardiovascular Systems Corporation	2	Air bubble detection cable assembly, catalog numbers 78-8067-7375-6 and 149892, Terumo Cardiovascular System, Ann Arbor, MI
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681834. Last updated year: 2026. Please use registration number 9681834 when referencing this establishment in official correspondence.