Biotrac Laboratories
Country not established
- Devices
- 2
What Biotrac Laboratories makes
Biotrac Laboratories manufactures the Eclipse Heart Support for Coronary Artery procedures, designed to provide temporary structural support during interventions. The company also produces the Coronary Anastomosis Marking System, which aids in precise surgical marking during coronary anastomosis procedures.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with products listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Eclipse Heart Support For Coronary Arter Ref K843216
Regimes: 510(k) Registry: 510(k)Coronary Anastomosis Marking System Ref K832806
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biotrac Laboratories have in the registry?
The registry currently lists 2 devices for Biotrac Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biotrac Laboratories's devices?
Among its 2 most recently registered devices, Biotrac Laboratories has devices listed in FDA 510(k) (2 devices).
What risk classes do Biotrac Laboratories's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Biotrac Laboratories's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biotrac Laboratories in the registry?
The most recently registered devices listed for Biotrac Laboratories include ECLIPSE HEART SUPPORT FOR CORONARY ARTER and CORONARY ANASTOMOSIS MARKING SYSTEM.