Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008307705

FEI Number

3008307705

Entity Name

Terumo Medical Canada, Inc.

City/State/Country

Vaughan Ontario, CA

Establishment Address

10911 Keele Street, Units 2-4, Vaughan Ontario L6A 5A6, CA

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

TERUMO MEDICAL CORP. (Owner Number: 9003933)

Owner / Operator Contact Address

265 Davidson Avenue, Ste. 320, Somerset, NJ 08873, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091417

PMA Number

N/A

All Registered Proprietary Names

Traxcess Docking Wire AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 Terumo Surguard2 with Safety Hypodermic Needle, Terumo Surguard2 Safety Syringe, Surguard2 Safety Hypodermic Needle, Terumo Surguard2 Safety Hypodermic Needle Surguard2 Safety Syringe, Surguard2 Safety Needle, Terumo Surguard2 Safety Needle, Glidesheath K-Pack Surshield Needle, Hypodermic Needle for Single Use CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER K-Pack II Needle-21G x 2 27G X 1/2 K-Pack II Needle - 29G x 5/16 Thin Wall AZUR Peripheral Hydrocoil Embolization System SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) LIPO-PORT WEB Aneurysm Embolization System Surshield Safety Winged Blood Collection Set Radifocus Glidecath, Radifocus Glidecath XP HydroFrame 18 Advanced HyperSoft 3D Advanced TREO Abdominal Stent-Graft System Azur Detachable 35 Platinum Coil System MicroPlex Cosmos Radifocus® Optitorque Angiographic Catheter HydroSoft 3D Advanced FRED 21 R2P NaviCross K-PACK II SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) Hypodermic Syringe Without Needle Radifocus Glidewire Advantage Angio-Seal VIP Vascular Closure Device Angio-Seal Terumo SurGuard3 Safety Hypodermic Needle CAPIOX AF125X ARTERIAL FILTER AZUR Peripheral Hydrocoil Endovascular Embolization Coil System AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 Glidewire Advantage Track Progreat TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER Traxcess CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR Radifocus Introducer II with R/O Marker Pinnacle R/O II Neuro Glidewires Headliner Hydrophilic Coated Guidewire; Glidewire Gold Neuro CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR K-PACK II NEEDLE- 27G & 30G THIN WALL CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER Cosmos 10 Advanced Surflo Winged Infusion Set R2P Destination Slender Guiding Sheath AZUR Peripheral Hydrocoil Embolization System HydroCoil® Embolic System (HES) MicroPlex® Coil System (MCS) Headway 17 Microcatheter CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR Glidewire GT, Glidewire Gold Radifocus Glidewire, Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath TERUMO HOLLOW OXYGENATOR CIRCUIT Radifocus Introducer II Pinnacle Introducer Sheath CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS AZUR Peripheral Hydrocoil Embolization System (Detachable 18) Glidesheath Slender HydroFill 10 Advanced Progreat Progreat Coaxial Microcatheter System Surflash IV Catheter SOFIA 6F Catheter AZUR Peripheral Hydrocoil Endovascular Embolization Coil System AZUR CX Coil System-Detachable 18 AZUR CX Finecross M3 CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR Heartrail III Coronary Guiding Catheter Radifocus Glidewire Radifocus Torque Device Terumo Syringe, Terumo Syringe w Needle Surflo Winged Infusion Set Azur Peripheral Hydrocoil Embolization System Detachable 35 HydroFill 10 Advanced R2P Destination Slender Guiding Sheath Runthrough NS Extension Wire CAPIOX FLEXIBLE VENOUS RESERVOIR Terumo Surflo I.V. Catheter K-PACK II NEEDLE - 27G X 3/4 THIN WALL Radifocus Glidewire Advantage 014 Glidesheath Slender Tibial Pedal Kit 29G AND 30G K-PACK II NEEDLE VIA-17 MICROCATHETER,VIA-17-154-01 Pinnacle R/O II HiFlo Terumo NaviCross Support Catheter Glidewire Gold Neuro X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR MicroPlex Cosmos Scepter Mini Occlusion Balloon Catheter RelayPro Thoracic Stent-Graft System HyperSoft Advanced AZUR CX Detachable 18 Peripheral Coil System K-PACK II NEEDLE - 29G THIN WALL Glidewire GT-R Navicross 018 Headway 27 Microcatheter Progreat Lambda MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) MicroPlex VFC Advanced CAPIOX CARDIOTOMY RESERVOIR Heartrail III 5Fr Guiding Catheter Chaperon Guiding Catheter,System Terumo®SurGuard®3 Safety Needle Terumo®SurGuard®3 Hypodermic Syringe with Safety Needle HydroFrame 10 Advanced Terumo Single Use Guidewire VisiGlide Single Use 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	2024-01-04
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-12-12
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2011-01-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2015-12-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-02-24
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-03-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-02-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-18
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2011-01-20
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2011-01-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-18
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2005-04-07
OPR	Intrasaccular Flow Disruption Device	Unknown	Class 3	N/A	2024-03-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-01-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-08-28
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-12-12
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-12-12
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2025-06-23
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-11-21
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2015-10-23
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-12-12
OUT	Intracranial Aneurysm Flow Diverter	Unknown	Class 3	N/A	2023-12-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-07-31
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-03-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2011-01-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-01-20
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2017-01-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-04-21
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2020-03-18
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-08-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-12-12
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2021-03-01
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2018-01-18
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2011-01-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-03-13
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-03-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-11-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-01-20
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-03-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-18
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-03-18
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2024-03-13
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-08-16
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-01-20
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2011-01-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-12-12
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-03-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-03
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-03-16
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2020-03-18
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	1996-04-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-03-18
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2014-10-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-05-10
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2024-03-13
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2011-01-20
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2011-01-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-10-09
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-10-09
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-02-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-09-09
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-03-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2011-01-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-03-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-01-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2011-01-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-01-20
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2011-07-14
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-12-12
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-10-25
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-01-20
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2020-03-18
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2014-12-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-04-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-12-11
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-06-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-06-26
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-12-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-07-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-01-20
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-03-18
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-10-11
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2025-02-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-12-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2025-11-20
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-09-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-03-13
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2022-04-13
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2022-04-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2024-10-09
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2020-03-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-08-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-12-12
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-01-09
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2013-01-09
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2023-12-12
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-12-12
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2011-01-20

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

TERUMO MEDICAL 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
3013394970	Terumo Puerto Rico LLC	Caguas, PR, US
2243441	TERUMO MEDICAL CORP.	Somerset, NJ, US
1118880	TERUMO MEDICAL CORP.	ELKTON, MD, US

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-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008307705. Last updated year: 2026. Please use registration number 3008307705 when referencing this establishment in official correspondence.