Data / Medical devices / Germany / Vascomed Inst Kathetertechnologie
Vascomed Inst Kathetertechnologie: FDA-registered device maker in BINZEN Baden-Wurttemberg, Germany, 2 510(k) clearances
Vascomed Inst Kathetertechnologie is registered with the FDA (registration 8043831) in BINZEN Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated October 15, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8043831
- FEI number
- 3002808439
- Address
- Hertzallee 1, BINZEN Baden-Wurttemberg, Germany, D79589
- Owner or operator
- VascoMed GmbH (9004075)
- Roles
- Manufacturer
- First device listed
- October 4, 2021
- Registered through
- 2027
- Brand names listed
- AcQRate DX Fixed Curve Catheter, AcQRate Dx Steerable Catheter, MPK-10-R, MPK-4-R, MultiCath, ViaCath
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 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 |
|---|---|---|---|---|---|---|
| October 15, 2021 | K212593 | ViaCath, AcQRate Dx Steerable Catheter | DRF | Substantially Equivalent | Biotronick, Inc. | accessdata.fda.gov |
| September 2, 2021 | K201445 | MultiCath, AcQRate Dx Fixed Curve Catheter | DRF | Substantially Equivalent | Biotronik, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 15, 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.