Ashitaka Factory of Terumo Corp.
FUJINOMIYA Shizuoka, JP
ASHITAKA FACTORY OF TERUMO CORP. appears in FDA device records in FUJINOMIYA Shizuoka, JP. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Ashitaka Factory of Terumo Corp. between 2013 and 2021. The busiest year on record is 2015, with 2. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203521 | FineCross M3 | DQY | Substantially Equivalent | |
| K170223 | Progreat | DQO | Substantially Equivalent | |
| K161546 | R2P SlenGuide | DQY | Substantially Equivalent | |
| K152740 | Radifocus Glidewire | DQX | Substantially Equivalent | |
| K150232 | Radifocus Optitorque Angiographic Catheter | DQO | Substantially Equivalent | |
| K130520 | CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR | DTZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9681834 | 3002808327 | ASHITAKA FACTORY OF TERUMO CORP. | 150 MAIMAIGI-CHO, FUJINOMIYA Shizuoka 418-0015 JP | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- OBJCatheter, Ultrasound, Intravascular
- KODCatheter, Urological
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- DXCClamp, Vascular
- FLLContinuous Measurement Thermometer
- KRLDetector, Bubble, Cardiopulmonary Bypass
- OCYEndoscopic Guidewire, Gastroenterology-Urology
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- NIOStent, Iliac
- NIPStent, Superficial Femoral Artery
- DQXWire, Guide, Catheter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain