Data / Medical devices / Switzerland / Vantive Health GmbH
Vantive Health GmbH: FDA-registered device maker in Glattpark (Opfikon) Zurich, Switzerland, 2 510(k) clearances
Vantive Health GmbH is registered with the FDA (registration 3033903155) in Glattpark (Opfikon) Zurich, Switzerland. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 25, 2019. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3033903155
- Address
- Thurgauerstrasse 130, Glattpark (Opfikon) Zurich, Switzerland, 8152
- Owner or operator
- Vantive US Healthcare LLC (9038727)
- Roles
- Exporter to the US
- First device listed
- September 6, 2019
- Registered through
- 2026
- Brand names listed
- PRISMAFLO, PrisMax System Version 2, TherMax, Tipstop
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Exporter to the US | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| July 25, 2019 | K190910 | PrisMax System Version 2 | KDI | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| December 19, 2008 | K082758 | PRISMAFLO II | KOC | Substantially Equivalent | Stihler Electronic GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Hydrophilic
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Accessories, Blood Circuit, Hemodialysis
Updated July 25, 2019. 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.