Polystan C/O Vitalcor, Inc. - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Polystan C/O Vitalcor, Inc. Cardiovascular ✕
7 devices
Cleared
Jan 18, 1990
POLYSTAN HEATER-COOLER UNIT
Cardiovascular
232d
Cleared
Dec 22, 1989
SAFE-1
Cardiovascular
218d
Cleared
Dec 22, 1989
SAFE-1 VENOUS RESERVOIR
Cardiovascular
218d
Cleared
Feb 05, 1988
POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS
Cardiovascular
72d
Cleared
Feb 05, 1988
POLYSTAN TWO STAGE CATHETERS
Cardiovascular
72d
Cleared
Oct 30, 1987
POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE
Cardiovascular
144d
Cleared
Oct 18, 1984
PO 2 LYTRODE
Cardiovascular
41d