Data / Medical devices / United States / Nipro Vascular Innovations Americas, Inc.
Nipro Vascular Innovations Americas, Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 1 510(k) clearance
Nipro Vascular Innovations Americas, Inc. is registered with the FDA (registration 3003524171) in Sunnyvale, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003524171
- Address
- 870 Hermosa Dr, Sunnyvale, CA, United States, 94085
- Owner or operator
- Nipro Vascular Innovations Americas, Inc. (9042740)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- November 17, 2015
- Registered through
- 2026
- Brand names listed
- Captus, Impax Versa, ImpaxOmega
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Neurovascular Embolization | HCG | 2 | Manufacturer for export | accessdata.fda.gov |
| Device, Percutaneous Retrieval | MMX | 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 |
|---|---|---|---|---|---|---|
| August 28, 2017 | K170987 | Captus Vascular Retrieval System | MMX | Substantially Equivalent | Avantec Vascular Corporation | accessdata.fda.gov |
Compare with other makers
Updated August 28, 2017. 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.