Polystan A/S is one of 44 FDA 510(k) medical device manufacturers from Denmark in the dataset, ranked by real submission volume.
Polystan A/S - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Polystan A/S has 6 FDA 510(k) cleared medical devices. Based in Denmark, DK.
Historical record: 6 cleared submissions from 1991 to 2002. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Polystan A/S Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Polystan A/S
6 devices
Cleared
Dec 04, 2002
PEDIATRIC ARTERIAL CANNULA
Cardiovascular
65d
Cleared
Aug 14, 2002
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
Cardiovascular
338d
Cleared
Aug 06, 2002
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
Cardiovascular
22d
Cleared
Oct 13, 2000
SAFE MINI
Cardiovascular
942d
Cleared
Feb 04, 1997
SAFE MICRO
Cardiovascular
531d
Cleared
Dec 04, 1991
SAFE II
Cardiovascular
208d