# Polystan A/S

- Location (FDA's records): Vaerlose, DK
- FDA decisions: 6 (1991–2002): 6 510(k) clearances
- Product codes: DTZ (4), DWF (1), DTN (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Jostra AG: 1 (https://510kreport.com/company/jostra)
- Gish Biomedical, Inc.: 1 (https://510kreport.com/company/gish-biomedical)
- Jostra Bentley: 1 (https://510kreport.com/company/jostra-bentley)

## Firms that cite its devices most
- Dideco S.P.A.: 1 (https://510kreport.com/company/dideco)

## Its most-cited devices
- K953976: Safe Micro (1997), cited by 1
- K980974: Safe Mini (2000), cited by 1

## Recent decisions
- K023251: Pediatric Arterial Cannula (Dec 4, 2002)
- K013038: Safe Maxi Hollow Fiber Oxygenator, Model 016010 (Aug 14, 2002)
- K022281: Safe Maxi Venous/Cardiotomy Reservior, Model 016045 (Aug 6, 2002)
- K980974: Safe Mini (Oct 13, 2000)
- K953976: Safe Micro (Feb 4, 1997)
- K912082: Safe II (Dec 4, 1991)

Source page: https://510kreport.com/company/polystan-a-s