Ackard Laboratories
Country not established
- Devices
- 2
What Ackard Laboratories makes
Ackard Laboratories manufactures the H/S Elliptosphere Catheter Set (Model 61-4005), a specialized catheter designed for specific cardiac procedures, and the PAO Valve, a percutaneously implanted heart valve intended for structural heart repair.
The company’s products are classified as Class II devices under FDA regulations and are listed via 510(k) clearance. Ackard Laboratories is based in the United States.
Catalogue
H/S Elliptosphere Catheter Set, Model 61-4005 Ref K013972
Regimes: 510(k) Registry: 510(k)Pao Value Ref K852990
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ackard Laboratories have in the registry?
The registry currently lists 2 devices for Ackard Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ackard Laboratories's devices?
Among its 2 most recently registered devices, Ackard Laboratories has devices listed in FDA 510(k) (2 devices).
What risk classes do Ackard Laboratories's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ackard Laboratories's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ackard Laboratories in the registry?
The most recently registered devices listed for Ackard Laboratories include H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005 and PAO VALUE.