Sorin Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE, CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE, DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sorin Biomedical, Inc. Cardiovascular ✕
13 devices
Cleared
Nov 05, 1999
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL...
Cardiovascular
297d
Cleared
Sep 03, 1997
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
Cardiovascular
268d
Cleared
Aug 21, 1997
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY...
Cardiovascular
255d
Cleared
Aug 12, 1996
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
Cardiovascular
89d
Cleared
Aug 21, 1995
DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON...
Cardiovascular
98d
Cleared
Jun 27, 1995
DIDECO PEDIATRIC ARTERIAL FILTERS
Cardiovascular
246d
Cleared
May 19, 1995
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
Cardiovascular
217d
Cleared
May 10, 1995
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
Cardiovascular
426d
Cleared
Jan 27, 1995
SORIN BLOOD CARDIOPLEGIA CONSOLE
Cardiovascular
240d
Cleared
Apr 15, 1994
SORIN BLOOD CARDIOPLEGIA SYSTEM
Cardiovascular
192d
Cleared
Apr 15, 1994
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
Cardiovascular
189d
Cleared
Mar 23, 1994
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
Cardiovascular
86d
Cleared
Nov 02, 1993
SORIN MONOLYTH VENOUS RESERVOIR
Cardiovascular
125d