Cardio Systems, Inc. - FDA 510(k) Cleared Devices
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardio Systems, Inc. Cardiovascular ✕
5 devices
Cleared
Jun 24, 2013
STEALTH 360 ORBITAL PAD SYSTEM
Cardiovascular
67d
Cleared
Aug 14, 2008
MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
Cardiovascular
37d
Cleared
Sep 15, 1992
CENTRI-SAFE(TM) VALVE
Cardiovascular
168d
Cleared
Nov 13, 1979
OXYGENATOR GAS LINE FILTER
Cardiovascular
22d
Cleared
Nov 13, 1979
CARDIOPLEGIA SOLUTION ADMIN. SET
Cardiovascular
22d