Data / Medical devices / Japan / Ashitaka Factory Of Terumo Corp.
Ashitaka Factory Of Terumo Corp.: FDA-registered device maker in FUJINOMIYA Shizuoka, Japan, 53 510(k) clearances and 1 PMA approval
Ashitaka Factory Of Terumo Corp. is registered with the FDA (registration 9681834) in FUJINOMIYA Shizuoka, Japan. It lists 21 device types. The FDA files 53 510(k) clearances and 1 PMA approval under its listings, the newest dated March 27, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681834
- FEI number
- 3002808327
- Address
- 150 Maimaigi-Cho, FUJINOMIYA Shizuoka, Japan, 418-0015
- Owner or operator
- TERUMO CORP. (8010026)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- February 12, 2002
- Registered through
- 2026
- Brand names listed
- CAPIOS FX 05 Baby-FX Hollow Fiber Oxygenator Model CX*FX05RW, CAPIOX Arterial Filter, CAPIOX Bubble Trap, CAPIOX Cardioplegia, CAPIOX FX Hollow Fiber Oxygenator, CAPIOX FX05 Hollow Fiber Oxygenator, CAPIOX FX05 Hollow Fiber Oxygenators/Reservoirs with Integrated Arterial Filter (with X-Coating), CAPIOX FX15 and FX25 Hollow Fiber Oxygenator/Reservoir with Integrated Arterial Filter (with X-Coating) 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 27, 2026 | K252295 | Ryurei | LOX | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| July 17, 2025 | K250751 | DualView Catheter | DQO | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| November 26, 2024 | K240818 | R2P Radifocus Glidewire Advantage | DQX | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| August 21, 2024 | K240859 | Glidewire GT-R | DQX | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| March 3, 2021 | K203521 | FineCross M3 | DQY | Substantially Equivalent | Ashitaka Factory of Terumo Corporation | accessdata.fda.gov |
| March 29, 2018 | K173799 | NaviCross 0.018 | DQY | Substantially Equivalent | Terumo 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 |
| January 30, 2017 | K163004 | Radifocus Glidewire Advantage Track | DQX | Substantially Equivalent | Ashitaka Factory of Terumo Coporation | accessdata.fda.gov |
| October 14, 2016 | K161546 | R2P SlenGuide | DQY | Substantially Equivalent | Ashitaka Factory of Terumo 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 |
| March 13, 2013 | K130520 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | DTZ | Substantially Equivalent | Ashitaka Factory of Terumo Corp. | accessdata.fda.gov |
| March 13, 2013 | K130493 | CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR | DTZ | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| March 13, 2013 | K130280 | CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR | DTZ | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| March 1, 2013 | K122590 | RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE | DQX | Substantially Equivalent | Terumo Medical Corporation | accessdata.fda.gov |
| July 16, 2012 | K113335 | HEARTRAIL III GUIDING CATHETER | DQO | Substantially Equivalent | Terumo Corporation | accessdata.fda.gov |
| May 13, 2011 | K110540 | TERUMO SUPPORT CATHETER | DQY | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 11, 2009 | K092372 | HEARTRAIL III GUIDING CATHETER | DQO | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| February 6, 2009 | K090040 | RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) | DQO | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 26, 2008 | K082519 | FINECROSS MG CORONARY MICRO-GUIDE CATHETER | KRA | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 24, 2008 | K082736 | RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| September 18, 2008 | K082644 | GLIDESHEATH | DYB | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| April 17, 2008 | K080774 | CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) | KFM | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | 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 |
| April 27, 2007 | K063695 | RUNTHROUGH NS | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| March 28, 2007 | K070423 | TR BAND | DXC | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| January 19, 2007 | K063372 | RADIFOCUS GLIDEWIRE ADVANTAGE | DQX | 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 |
| 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 |
| 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 |
| September 27, 2002 | K022115 | CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR | DTZ | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| August 10, 1999 | K992051 | RADIFOCUS OPTITORQUE | DQO | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| June 23, 1999 | K982467 | CAPIOX CARDIOPLEGIA | DTR | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| February 25, 1997 | K962981 | CAPIOX SP PUMP HEAD | KFM | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| February 2, 1996 | K955801 | RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| August 15, 1995 | K943861 | CAPIOX SP PUMP HEAD | KFM | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| July 25, 1995 | K943917 | CAPIOX ARTERIAL FILTER | DTM | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| April 29, 1993 | K926214 | GUIDE WIRE FOR LAPOROSCOPIC USE | GCJ | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| November 23, 1992 | K924202 | RADIFOCUS(R) (CATHETER) GUIDE WIRE | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| October 2, 1992 | K923607 | RADIFOCUS GUIDE WIRE M | KOD | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| February 4, 1992 | K915414 | TERUMO ANGIOGTAPHIC CATHETER | DQO | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| November 5, 1991 | K913074 | 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| July 9, 1991 | K911632 | CAPIOX(R) BUBBLE TRAP | KRL | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| May 16, 1991 | K910969 | TORQUE DEVICE FOR A GUIDE WIRE | DQX | Substantially Equivalent | Terumo Corp. | accessdata.fda.gov |
| November 20, 1986 | K863138 | TERUMO RADIFOCUS GUIDE WIRE | DQX | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| June 27, 1985 | K852087 | CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS | FLL | Substantially Equivalent | Terumo Medical Corp. | accessdata.fda.gov |
| December 14, 1981 | K812659 | TERUMO HOLLOW OXYGENATOR CIRCUIT | DTM | Substantially Equivalent | Terumo Medical 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 |
|---|---|---|---|---|---|---|
| May 22, 2015 | P140002 | MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM | NIP | 31 | July 16, 2026 | accessdata.fda.gov |
Compare with other makers
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- All makers of Catheter, Intravascular, Diagnostic
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Updated July 16, 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.