Data / Medical devices / Vietnam / KANEKA MEDICAL VIETNAM Co.,Ltd.
KANEKA MEDICAL VIETNAM Co.,Ltd.: FDA-registered device maker in Ho Chi Minh, Vietnam, 4 510(k) clearances
KANEKA MEDICAL VIETNAM Co.,Ltd. is registered with the FDA (registration 3031550970) in Ho Chi Minh, Vietnam. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031550970
- Address
- 35 VSIP Street 6, Vietnam - Singapore Industrial Park, An Phu Word, Ho Chi Minh, Vietnam, NA
- Owner or operator
- KANEKA CORP. (9005249)
- Roles
- Manufacturer
- First device listed
- April 9, 2017
- Registered through
- 2026
- Brand names listed
- EDG v4, OTW Takeru, RX NC Takeru, RX Takeru, i-ED COIL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer | accessdata.fda.gov |
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer | accessdata.fda.gov |
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 26, 2021 | K210638 | i-ED COIL System | HCG | Substantially Equivalent | Kaneka Medical America, LLC | accessdata.fda.gov |
| March 19, 2018 | K172264 | OTW Takeru PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| July 7, 2017 | K170941 | RX NC Takeru PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
| April 7, 2017 | K163372 | RX Takeru Balloon Dilatation Catheter | LOX | Substantially Equivalent | KANEKA Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Device, Neurovascular Embolization
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
Updated March 26, 2021. 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.