Arrow International, Teleflex
Country not established
- Devices
- 1
What Arrow International, Teleflex makes
Arrow International, part of Teleflex, manufactures the AC3 Series Intra-Aortic Balloon Pump (IABP), a mechanical circulatory support device used to assist heart function during critical cardiac events by inflating and deflating a balloon within the aorta to improve blood flow and reduce myocardial oxygen demand.
The AC3 Series IABP is classified as a Class II device under FDA regulations and is authorised via the 510(k) clearance process. The manufacturer is based in the United States.
Catalogue
AC3 Series Intra-Aortic Balloon Pump (IABP) Ref K192238
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Arrow International, Teleflex have in the registry?
The registry currently lists 1 device for Arrow International, Teleflex. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arrow International, Teleflex's devices?
Among its 1 most recently registered device, Arrow International, Teleflex has devices listed in FDA 510(k) (1 device).
What risk classes do Arrow International, Teleflex's devices fall under?
Among its 1 most recently registered device, the classes recorded for Arrow International, Teleflex's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Arrow International, Teleflex in the registry?
The most recently registered devices listed for Arrow International, Teleflex include AC3 Series Intra-Aortic Balloon Pump (IABP).