Polystan A/S
DenmarkFDA applicant, unverified
- Devices
- 6
What Polystan A/S makes
Polystan A/S makes medical devices such as oxygenators, cannulas, and reservoirs. Their products include the SAFE MINI, SAFE MAXI HOLLOW FIBER OXYGENATOR, and PEDIATRIC ARTERIAL CANNULA, which are used in medical procedures.
The company's portfolio is classified as Class II devices and is listed in the FDA 510(k) registry. Polystan A/S is based in the US.
Catalogue
Safe Mini Ref K980974
Regimes: 510(k) Registry: 510(k)Safe Maxi Hollow Fiber Oxygenator, Model 016010 Ref K013038
Regimes: 510(k) Registry: 510(k)Safe Ii Ref K912082
Regimes: 510(k) Registry: 510(k)Safe Micro Ref K953976
Regimes: 510(k) Registry: 510(k)Pediatric Arterial Cannula Ref K023251
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Polystan A/S have in the registry?
The registry currently lists 6 devices for Polystan A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polystan A/S's devices?
Among its 6 most recently registered devices, Polystan A/S has devices listed in FDA 510(k) (6 devices).
What risk classes do Polystan A/S's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Polystan A/S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Polystan A/S in the registry?
The most recently registered devices listed for Polystan A/S include SAFE MINI, SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010, SAFE II and SAFE MICRO.