TERUMO CORP.

FDA Device Registration & Listing · SHIBUYA-KU, TOKYO, JP · Registration 8010026

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8010026
FEI Number
2828
Entity Name
TERUMO CORP.
City/State/Country
SHIBUYA-KU, TOKYO, JP
Establishment Address
44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO 151-0072, JP
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
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
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

R2P SlenGuide CAPIOX® AF125X Arterial Filter DualView Catheter Glidewire GT Guide Wire M and Tapered Glidewire Gold Radifocus Guide Wire G-240-3527S G-240-3545A VisiGlide Single Use Guidewire G-240-2527A G-240-3545S G-240-2545S Radifocus Glidewire® Endoscopic Wire G-240-3527A Single Use Guidewire G-240-2527S G-240-2545A MISAGO RX Self-expanding Peripheral Stent Heartrail III 5Fr Guiding Catheter Glidewire Radifocus Guide Wire for laparoscopic use Ryurei Heartrail III Coronary Guiding Catheter Radifocus Glidecath Radifocus Glidewire Radifocus Glidecath Hydrophilic Coated Catheter CHAPERON GUIDING CATHETER TRAXCESS 014" HYDROPHILIC GUIDEWIRE TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE CAPIOX® RX15 Hollow Fiber Oxygenator w/without Hardshell Reservoir R2P Radifocus Glidewire Advantage Glidewire Gold Neuro Neuro Glidewires Headliner Hydrophilic Coated Guidewire CAPIOX® RX05 Hollow Fiber Oxygenator with/without Hardshell Reservoir Terumo Hollow Fiber Oxygenator Circuit CAPIOX Cardioplegia Progreat Progreat Coaxial Microcatheter System Progreat CAPIOX Arterial Filter CAPIOX® RX25 Hollow Fiber Oxygenator with/without Hardshell Reservoir TRAXCESS DOCKING WIRE with Integrated Arterial Filter CAPIOX FX05 Hollow Fiber Oxygenator Radifocus Glidewire Glidewire GT Glidewire Gold Obturator Glidesheath CAPIOX SP Pump (With or Without X-Coating) Radifocus Torque Device Capiox SP Pump Runthrough NS Extension Wire Glidewire GT-R FineCross M3 CAPIOX FX Hollow Fiber Oxygenator with Integrated Arterial Filter Holder for CAPIOX® SX18 Holder for CAPIOX® SX18R CAPIOX® FX Holder CAPIOX® CR Holder Holder for CAPIOX® Sampling Manifold CAPIOX® Cardiotomy Reservoir Holder Holder for CAPIOX® Oxygenator with Reservoir Holder for CAPIOX® Filters and Bubble Traps Holder for CAPIOX® Oxygenator Holder for CAPIOX® RX/FX 15 & 25 Oxygenators Radifocus Glidewire Advantage Immucise Intradermal Injection System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2016-12-16
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2007-11-30
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2025-07-23
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-07-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-09-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-30
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2021-11-15
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2015-05-27
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-07-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-11-30
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2026-04-01
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2009-09-15
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2009-02-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-11-17
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-11-30
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-12-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-05-05
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 2025-04-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-30
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2007-11-30
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2007-11-30
DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular Class 2 870.4240 2007-11-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2007-11-30
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2017-09-08
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2007-11-30
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2007-11-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2010-03-01
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2008-07-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-30
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-10-06
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2015-04-24
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 2007-11-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-03-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-01-31
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-03-15
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2008-07-25
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2002-02-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-05-28
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2025-05-28

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
9681834 ASHITAKA FACTORY OF TERUMO CORP. FUJINOMIYA Shizuoka, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K043580 Chestnut Medical Technologies, Inc. ALLIGATOR RETRIEVAL DEVICE (ARD) 2005-03-24
K982883 Medtronics Interventional Vascular MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER 1998-09-04
K132420 Reflow Medical WINGMAN EXTENDABLE TIP SUPPORT CATHETER 2013-09-19
K082339 Endocross, Ltd. ENABLER-P SUPPORT CATHETER 2008-11-20
K210009 CenterPoint Systems, LLC Guiding Catheter 2021-11-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04 Bard Peripheral Vascular 2
Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010026. Last updated year: 2026. Please use registration number 8010026 when referencing this establishment in official correspondence.
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