Medical Device Manufacturer · US , Irvine , CA

Sorin Biomedical, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1993
15
Total
15
Cleared
0
Denied

Sorin Biomedical, Inc. has 15 FDA 510(k) cleared cardiovascular devices. Based in Irvine, US.

Historical record: 15 cleared submissions from 1993 to 1999.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Sorin Biomedical, Inc.
15 devices
1-15 of 15
Cleared Nov 05, 1999
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL...
K990103 · DTZ
Cardiovascular · 297d
Cleared Feb 20, 1998
CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINE
K963758 · CAC
Anesthesiology · 520d
Cleared Feb 20, 1998
DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMS
K963759 · CAC
Anesthesiology · 520d
Cleared Sep 03, 1997
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
K964908 · DTN
Cardiovascular · 268d
Cleared Aug 21, 1997
VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY...
K964907 · DTN
Cardiovascular · 255d
Cleared Aug 12, 1996
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
K961869 · DTM
Cardiovascular · 89d
Cleared Aug 21, 1995
DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON...
K952270 · DTM
Cardiovascular · 98d
Cleared Jun 27, 1995
DIDECO PEDIATRIC ARTERIAL FILTERS
K945198 · DTM
Cardiovascular · 246d
Cleared May 19, 1995
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
K945065 · DTN
Cardiovascular · 217d
Cleared May 10, 1995
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
K941215 · DTN
Cardiovascular · 426d
Cleared Jan 27, 1995
SORIN BLOOD CARDIOPLEGIA CONSOLE
K942582 · DTQ
Cardiovascular · 240d
Cleared Apr 15, 1994
SORIN BLOOD CARDIOPLEGIA SYSTEM
K934763 · DTN
Cardiovascular · 192d
Cleared Apr 15, 1994
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
K934847 · DTN
Cardiovascular · 189d
Cleared Mar 23, 1994
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
K936183 · DTN
Cardiovascular · 86d
Cleared Nov 02, 1993
SORIN MONOLYTH VENOUS RESERVOIR
K933481 · DTN
Cardiovascular · 125d
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