Big Blue Biotech, Inc.
Country not established
- Devices
- 1
What Big Blue Biotech, Inc. makes
Big Blue Biotech, Inc. manufactures the Wiygul Catheter, a medical device designed for specific vascular or procedural applications. This catheter is intended for use in interventional radiology or cardiology procedures, providing targeted delivery or drainage within the body’s circulatory system.
The Wiygul Catheter is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is headquartered in the United States, where its products are subject to compliance with U.S. medical device authorization requirements.
Catalogue
Wiygul Catheter Ref K202566
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Big Blue Biotech, Inc. have in the registry?
The registry currently lists 1 device for Big Blue Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Big Blue Biotech, Inc.'s devices?
Among its 1 most recently registered device, Big Blue Biotech, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Big Blue Biotech, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Big Blue Biotech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Big Blue Biotech, Inc. in the registry?
The most recently registered devices listed for Big Blue Biotech, Inc. include Wiygul Catheter.