Polystan C/O Vitalcor, Inc.
Medical device manufacturer in Denmark, DK.
8510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K894657 | Polystan Heart-Lung Machine SystemDJQ · Traditional | 03/28/1990SE |
| K893940 | Polystan Heater-Cooler UnitDWC · Traditional | 01/18/1990SE |
| K893705 | SAFE-1 Venous ReservoirDTN · Traditional | 12/22/1989SE |
| K893704 | SAFE-1DTZ · Traditional | 12/22/1989SE |
| K874853 | Polystan Two Stage CathetersDWF · Traditional | 02/05/1988SE |
| K874852 | Polystan Wire Reinforced Two Stage CathetersDWF · Traditional | 02/05/1988SE |
| K872182 | Polystan Wire Reinforced Catheters and CannulaeDQY · Traditional | 10/30/1987SE |
| K843538 | Po 2 LytrodeDRY · Traditional | 10/18/1984SE |