B.J. Star, Inc.
Country not established
- Devices
- 1
What B.J. Star, Inc. makes
B.J. Star, Inc. manufactures silicone Foley balloon catheters designed for urinary drainage in clinical and home healthcare settings. These devices feature a flexible silicone construction intended for patient comfort and reduced risk of irritation during prolonged use.
The company’s silicone Foley balloon catheters are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The products are intended for use in the United States, where they must comply with FDA requirements for urinary drainage devices.
Catalogue
Bj Star All Silicone Foley Balloon Catheter Ref K900022
510(k) 510(k)
Frequently asked questions
How many devices does B.J. Star, Inc. have in the registry?
The registry currently lists 1 device for B.J. Star, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list B.J. Star, Inc.'s devices?
Among its 1 most recently registered device, B.J. Star, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do B.J. Star, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for B.J. Star, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from B.J. Star, Inc. in the registry?
The most recently registered devices listed for B.J. Star, Inc. include BJ STAR ALL SILICONE FOLEY BALLOON CATHETER.