Biotronick, Inc.
Country not established
- Devices
- 1
What Biotronick, Inc. makes
Biotronick, Inc. manufactures steerable catheters, including the ViaCath and AcQRate Dx models, designed for precise medical procedures. These devices are intended for use in diagnostic and interventional applications within vascular systems.
The company’s products fall under FDA Class II regulatory classification and are authorised through the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry, and the manufacturer operates from the United States.
Catalogue
ViaCath, AcQRate Dx Steerable Catheter Ref K212593
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotronick, Inc. have in the registry?
The registry currently lists 1 device for Biotronick, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotronick, Inc.'s devices?
Among its 1 most recently registered device, Biotronick, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Biotronick, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Biotronick, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotronick, Inc. in the registry?
The most recently registered devices listed for Biotronick, Inc. include ViaCath, AcQRate Dx Steerable Catheter.