Data / Medical devices / Canada / Terumo Medical Canada, Inc.
Terumo Medical Canada, Inc.: FDA-registered device maker in Vaughan Ontario, Canada, 121 510(k) clearances and 7 PMA approvals
Terumo Medical Canada, Inc. is registered with the FDA (registration 3008307705) in Vaughan Ontario, Canada. It lists 30 device types. The FDA files 121 510(k) clearances and 7 PMA approvals under its listings, the newest dated February 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008307705
- Address
- 10911 Keele Street Units 2-4, Vaughan Ontario, Canada, L6A 5A6
- Owner or operator
- TERUMO MEDICAL CORP. (9003933)
- Roles
- Exporter to the US
- First device listed
- April 15, 1996
- Registered through
- 2026
- Brand names listed
- 27G X 1/2, 29G AND 30G K-PACK II NEEDLE, AZUR CX Coil System-Detachable 18 AZUR CX, AZUR CX Detachable 18 Peripheral Coil System, AZUR CX Peripheral Coil System Detachable 35, AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35, AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35, AZUR Peripheral Hydrocoil Embolization System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 121.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 27, 2025 | K241550 | Gelweave Vascular Prostheses | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| November 15, 2024 | K241070 | Gelsoft Plus Vascular Prostheses | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| August 21, 2024 | K240859 | Glidewire GT-R | DQX | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| July 27, 2023 | K231044 | R2P Navicross | DQY | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| June 23, 2023 | K221411 | Surflo Winged Infusion Set | FPA | Substantially Equivalent | Terumo Medical Products (Hangzhou) Co., Ltd. | accessdata.fda.gov |
| December 21, 2021 | K211078 | Progreat Lambda | DQO | Substantially Equivalent | Terumo Clinical Supply Co., Ltd. | accessdata.fda.gov |
| March 3, 2021 | K203521 | FineCross M3 | DQY | Substantially Equivalent | Ashitaka Factory of Terumo Corporation | accessdata.fda.gov |
| January 6, 2020 | K193125 | R2P Destination Slender Guiding Sheath | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| December 24, 2019 | K192135 | VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| December 3, 2019 | K193160 | Glidesheath Slender Tibial Pedal Kit | DYB | Substantially Equivalent | Terumo Medical Coporation | accessdata.fda.gov |
| July 10, 2019 | K182829 | Scepter Mini Occlusion Balloon Catheter | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| May 8, 2018 | K173831 | Glidesheath Slender | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| March 29, 2018 | K173799 | NaviCross 0.018 | DQY | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| November 21, 2017 | K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| October 5, 2017 | K171491 | R2P Destination Slender Guiding Sheath | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| September 15, 2017 | K170417 | Glidewire GT | DQX | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| July 21, 2017 | K170223 | Progreat | DQO | Substantially Equivalent | Ashitaka Factory of Terumo Corporation | accessdata.fda.gov |
| June 30, 2017 | K162794 | Gelweave Vascular Grafts | DSY | Substantially Equivalent | Vascutek, Ltd. | accessdata.fda.gov |
| March 3, 2017 | K162524 | AZUR CX Detachable 18 Peripheral Coil System | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| January 30, 2017 | K163004 | Radifocus Glidewire Advantage Track | DQX | Substantially Equivalent | Ashitaka Factory of Terumo Coporation | accessdata.fda.gov |
| August 31, 2016 | K161367 | HydroCoil Embolic System (HES) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| January 22, 2016 | K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| December 1, 2015 | K152173 | Glidesheath | DYB | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| November 16, 2015 | K152740 | Radifocus Glidewire | DQX | Substantially Equivalent | Ashitaka Factory of Terumo Corp. | accessdata.fda.gov |
| October 19, 2015 | K150232 | Radifocus Optitorque Angiographic Catheter | DQO | Substantially Equivalent | Ashitaka Factory of Terumo Corp. | accessdata.fda.gov |
| October 16, 2015 | K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| September 25, 2015 | K151358 | AZUR CX Detachable 35 Coils | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| September 17, 2015 | K151471 | Radifocus Glidewire Endoscopic Wire | OCY | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| June 25, 2015 | K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| April 1, 2015 | K150263 | K-Pack II Needle-21G x 2 | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| March 27, 2015 | K150366 | SOFIA 6F Catheter | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| March 26, 2015 | K142449 | Headway 27 Microcatheter | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| June 12, 2014 | K133280 | TERUMO SURFLO I.V. CATHETER | FOZ | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| March 18, 2014 | K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| February 5, 2014 | K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| December 20, 2013 | K133626 | AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| October 28, 2013 | K132083 | AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| October 4, 2013 | K131948 | MICROPLEX COIL SYSTEM (MCS) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| September 6, 2013 | K132233 | K-PACK II NEEDLE - 27G X 3/4 THIN WALL | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| June 17, 2013 | K130577 | AZUR PUSHABLE 18 & 35 SYSTEM | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| March 1, 2013 | K122590 | RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE | DQX | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| November 28, 2012 | K123384 | AZUR CX DETACHABLE 18 | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| November 8, 2012 | K121607 | TERUMO(R) NEEDLE | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| August 29, 2012 | K122316 | AZUR DETACHABLE 35 | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| August 28, 2012 | K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| July 16, 2012 | K113335 | HEARTRAIL III GUIDING CATHETER | DQO | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| March 28, 2012 | K120630 | AZUR DETACHABLE 18 | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| March 5, 2012 | K113422 | TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | Substantially Equivalent | Terumo (Philippines) Corporation | accessdata.fda.gov |
| December 16, 2011 | K113457 | HYDROCOIL EMBOLIC SYSTEM (HES) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| December 14, 2011 | K112382 | TERUMO ASPRIATION CATHETER | QEZ | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| October 3, 2011 | K111606 | PINNACLE PRECISION ACCESS SYSTEM | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 29, 2011 | K112226 | HYDROCOIL EMBOLIC SYSTEM (HES) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| September 22, 2011 | K111797 | 27 G X 1/2 K-PACK SURSHIELD NEEDLE | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| September 20, 2011 | K111451 | MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| June 15, 2011 | K111307 | AZUR DETACHABLE 35 PLATINUM COIL SYSTEM | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| June 9, 2011 | K110850 | K-PACK II NEEDLE- 27G & 30G THIN WALL | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| June 6, 2011 | K110527 | K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| May 13, 2011 | K110540 | TERUMO SUPPORT CATHETER | DQY | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| April 28, 2011 | K103758 | MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| April 22, 2010 | K100454 | HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| February 26, 2010 | K100282 | TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER | FOZ | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| February 24, 2010 | K093647 | TRAXCESS DOCKING WIRE | DQX | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| January 15, 2010 | K093358 | MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| November 5, 2009 | K093160 | HEADWAY 21 MICROCATHETER, MODEL: MC212150S | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| October 28, 2009 | K093002 | AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 | KRD | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| September 11, 2009 | K092372 | HEARTRAIL III GUIDING CATHETER | DQO | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| June 30, 2009 | K091641 | HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| June 22, 2009 | K090891 | MICROPLEX COIL SYSTEM-COSMOS | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| May 22, 2009 | K091417 | SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A | OCY | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| April 10, 2009 | K090357 | HYDROFRAME (HES) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| March 12, 2009 | K090168 | AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415 | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| February 6, 2009 | K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | DQO | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| December 11, 2008 | K082385 | CHAPERON GUIDING CATHETER | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| December 4, 2008 | K083343 | HEADWAY 17 MICROCATHETER | DQY | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| October 29, 2008 | K082847 | PINNACLE ROII INTRODUCER SHEATH | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| October 23, 2008 | K082820 | K-PACK II NEEDLE - 29G THIN WALL | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| April 17, 2008 | K080863 | TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE | DQX | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| March 20, 2008 | K080563 | RUNTHROUGH NS EXTENSION WIRE | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| July 23, 2007 | K071572 | CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER | DTZ | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| July 16, 2007 | K071494 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER | DTZ | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| June 15, 2007 | K070656 | HYDROCOIL EMBOLIC SYSTEM (HES) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| April 27, 2007 | K063695 | RUNTHROUGH NS | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| January 19, 2007 | K063372 | RADIFOCUS GLIDEWIRE ADVANTAGE | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| December 26, 2006 | K063613 | MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| October 23, 2006 | K062446 | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 15, 2006 | K062608 | 29G AND 30G K-PACK II NEEDLE | FMI | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| September 27, 2005 | K051865 | TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR | MEG | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 15, 2005 | K051997 | CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| September 12, 2005 | K052205 | CAPIOX AF125X ARTERIAL FILTER | DTM | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| August 16, 2005 | K052034 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| June 28, 2005 | K050954 | MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) | HCG | Substantially Equivalent | MicroVention, Inc. | accessdata.fda.gov |
| March 11, 2004 | K033913 | PROGREAT | KRA | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| March 3, 2004 | K040210 | CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| March 1, 2004 | K040023 | CAPIOX FLEXIBLE VENOUS RESERVOIR | DTN | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
| February 10, 2004 | K033800 | CAPIOX CARDIOTOMY RESERVOIR | DTN | Substantially Equivalent | Terumo Cardiovascular Systems Corporation | accessdata.fda.gov |
| December 12, 2003 | K033583 | PROGREAT | DQO | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| May 30, 2003 | K031279 | SURSHIELD SAFETY WINGED BLOOD COLLECTION SET | FPA | Substantially Equivalent | Terumo Medical Products Hangzhou Co., Ltd. | accessdata.fda.gov |
| May 30, 2003 | K031266 | SURSHIELD SAFETY WINGED INFUSION SET | FPA | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| December 18, 2002 | K023271 | TERUMO SYRINGE WITH/WITHOUT NEEDLE | FMF | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 27, 2002 | K022115 | CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 19, 2022 | P210006 | Thoraflex Hybrid | QSK | 18 | September 8, 2026 | accessdata.fda.gov |
| August 5, 2021 | P200045 | RelayPro Thoracic Stent-Graft System | MIH | 20 | June 18, 2026 | accessdata.fda.gov |
| May 4, 2020 | P190015 | TREO® Abdominal Stent-Graft System | MIH | 27 | June 18, 2026 | accessdata.fda.gov |
| December 16, 2019 | P180027 | Flow Re-Direction Endoluminal Device (FRED®) System | OUT | 13 | November 2, 2025 | accessdata.fda.gov |
| December 31, 2018 | P170032 | Woven EndoBridge (WEB) Aneurysm Embolization System | OPR | 20 | May 28, 2026 | accessdata.fda.gov |
| May 30, 2018 | P170013 | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. | QCA | 12 | September 16, 2026 | accessdata.fda.gov |
| September 30, 1996 | P930038 | Angio Seal Vascular Closure Device | MGB | 99 | August 4, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Wire, Guide, Catheter
- All makers of Set, Administration, Intravascular
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Catheter, Continuous Flush
Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.