Polystan C/O Vitalcor, Inc.
Country not established
- Devices
- 8
What Polystan C/O Vitalcor, Inc. makes
The company manufactures single-use and reusable medical devices for cardiovascular and renal applications, including reinforced catheters and cannulae for vascular access, two-stage catheters for hemodialysis, and venous reservoirs for blood collection. It also produces heater-cooler units for temperature-controlled perfusion, lytrodes for electrophysiology procedures, and heart-lung machine systems for extracorporeal circulation.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The manufacturer is based in the United States.
Catalogue
Polystan Two Stage Catheters Ref K874853
Regimes: 510(k) Registry: 510(k)Polystan Heater-Cooler Unit Ref K893940
Regimes: 510(k) Registry: 510(k)Po 2 Lytrode Ref K843538
Regimes: 510(k) Registry: 510(k)Polystan Wire Reinforced Catheters And Cannulae Ref K872182
Regimes: 510(k) Registry: 510(k)Polystan Wire Reinforced Two Stage Catheters Ref K874852
Regimes: 510(k) Registry: 510(k)Polystan Heart-Lung Machine System Ref K894657
Regimes: 510(k) Registry: 510(k)Safe-1 Venous Reservoir Ref K893705
Regimes: 510(k) Registry: 510(k)Safe-1 Ref K893704
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Polystan C/O Vitalcor, Inc. have in the registry?
The registry currently lists 8 devices for Polystan C/O Vitalcor, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polystan C/O Vitalcor, Inc.'s devices?
Among its 8 most recently registered devices, Polystan C/O Vitalcor, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Polystan C/O Vitalcor, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Polystan C/O Vitalcor, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Polystan C/O Vitalcor, Inc. in the registry?
The most recently registered devices listed for Polystan C/O Vitalcor, Inc. include POLYSTAN TWO STAGE CATHETERS, POLYSTAN HEATER-COOLER UNIT, PO 2 LYTRODE and POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE.