# Polystan C/O Vitalcor, Inc.

- Location (FDA's records): Denmark, DK
- FDA decisions: 8 (1984–1990): 8 510(k) clearances
- Product codes: DWF (2), DRY (1), DWC (1), DQY (1), DJQ (1), DTZ (1), DTN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K894657: Polystan Heart-Lung Machine System (Mar 28, 1990)
- K893940: Polystan Heater-Cooler Unit (Jan 18, 1990)
- K893704: SAFE-1 (Dec 22, 1989)
- K893705: Safe-1 Venous Reservoir (Dec 22, 1989)
- K874852: Polystan Wire Reinforced Two Stage Catheters (Feb 5, 1988)
- K874853: Polystan Two Stage Catheters (Feb 5, 1988)
- K872182: Polystan Wire Reinforced Catheters and Cannulae (Oct 30, 1987)
- K843538: PO 2 Lytrode (Oct 18, 1984)

Source page: https://510kreport.com/company/polystan-c-o-vitalcor