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Cobe Cardiovascular, Inc.

FDA 510(k) & PMA Approved Devices — 43 products

Total Devices43
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K050111 SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGDTN2005-03-08 View
510(k) K042473 COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMJQC2004-11-19 View
510(k) K040184 DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERDTM2004-02-26 View
510(k) K033641 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800DTN2003-12-11 View
510(k) K030462 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700KFM2003-03-06 View
510(k) K021830 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEMDTR2002-07-02 View
510(k) K011835 COBE REVOLUTIONKFM2002-02-12 View
510(k) K013480 COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATORDTZ2001-11-16 View
510(k) K012763 SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEMDRT2001-11-15 View
510(k) K001509 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAEDWF2001-10-26 View
510(k) K012898 MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEMDTR2001-09-17 View
510(k) K004046 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRDTP2001-04-26 View
510(k) K002493 DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTERDTM2000-11-30 View
510(k) K002591 COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRDTP2000-09-13 View
510(k) K994209 STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIPDWF2000-06-14 View
510(k) K000255 COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATORDTZ2000-04-25 View
510(k) K994389 COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTEREDDTN2000-03-27 View
510(k) K993001 COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTEREDDTN1999-12-03 View
510(k) K991452 COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATORDTZ1999-10-07 View
510(k) K991986 COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTIONCAC1999-09-09 View
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