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Sorin Biomedical, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K990103 MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHEDTZ1999-11-05 View
510(k) K963759 DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMSCAC1998-02-20 View
510(k) K963758 CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAW LINECAC1998-02-20 View
510(k) K964908 VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTERDTN1997-09-03 View
510(k) K964907 VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTOMY FILTER/MIDICARD PEDIATRIC CARDIOTOMY RESERVOIR WITH FILTDTN1997-08-21 View
510(k) K961869 DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40DTM1996-08-12 View
510(k) K952270 DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREENDTM1995-08-21 View
510(k) K945198 DIDECO PEDIATRIC ARTERIAL FILTERSDTM1995-06-27 View
510(k) K945065 DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063DTN1995-05-19 View
510(k) K941215 VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIRDTN1995-05-10 View
510(k) K942582 SORIN BLOOD CARDIOPLEGIA CONSOLEDTQ1995-01-27 View
510(k) K934763 SORIN BLOOD CARDIOPLEGIA SYSTEMDTN1994-04-15 View
510(k) K934847 NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMSDTN1994-04-15 View
510(k) K936183 SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMSDTN1994-03-23 View
510(k) K933481 SORIN MONOLYTH VENOUS RESERVOIRDTN1993-11-02 View
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