Sorin Group Italia S.R.L. - FDA 510(k) Cleared Devices
61
Total
61
Cleared
0
Denied
61 devices
Cleared
Oct 29, 2007
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL...
Cardiovascular
91d
Cleared
Sep 12, 2007
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN...
Cardiovascular
26d
Cleared
Jan 11, 2007
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN...
Cardiovascular
76d
Cleared
Jun 27, 2006
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
Cardiovascular
25d
Cleared
Jun 02, 2006
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH...
Cardiovascular
49d
Cleared
Apr 18, 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
Cardiovascular
86d
Cleared
Jun 18, 2001
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE...
Cardiovascular
77d
Cleared
Mar 30, 2001
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE...
Cardiovascular
270d
Cleared
Jul 28, 1998
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
Cardiovascular
85d
Cleared
Aug 26, 1997
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
Cardiovascular
54d
Cleared
Jun 02, 1995
AORTIC ARCH CANNULAS
Cardiovascular
294d