FDA 510(k) Applications Submitted by COBE CARDIOVASCULAR, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K030462 02/12/2003 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 COBE CARDIOVASCULAR, INC.
K050111 01/18/2005 SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG COBE CARDIOVASCULAR, INC.
K042473 09/13/2004 COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM COBE CARDIOVASCULAR, INC.
K993001 09/07/1999 COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED COBE CARDIOVASCULAR, INC.
K990239 01/25/1999 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC.
K040184 01/26/2004 DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER COBE CARDIOVASCULAR, INC.
K000255 01/28/2000 COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR COBE CARDIOVASCULAR, INC.
K980786 03/02/1998 COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800 COBE CARDIOVASCULAR, INC.
K991452 04/26/1999 COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR COBE CARDIOVASCULAR, INC.
K981613 05/06/1998 COBE SMARXT TUBING AND CONNECTORS COBE CARDIOVASCULAR, INC.
K001509 05/15/2000 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE COBE CARDIOVASCULAR, INC.
K011835 06/12/2001 COBE REVOLUTION COBE CARDIOVASCULAR, INC.
K991986 06/14/1999 COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION COBE CARDIOVASCULAR, INC.
K982254 06/26/1998 COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD COBE CARDIOVASCULAR, INC.
K982406 07/10/1998 COBE VACUUM RELIEF CHECK VALVE COBE CARDIOVASCULAR, INC.
K002493 08/14/2000 DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER COBE CARDIOVASCULAR, INC.
K012763 08/17/2001 SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM COBE CARDIOVASCULAR, INC.
K002591 08/21/2000 COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC.
K012898 08/29/2001 MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM COBE CARDIOVASCULAR, INC.
K973627 09/24/1997 STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM COBE CARDIOVASCULAR, INC.
K974085 10/29/1997 COBE OXYGENATOR PRODUCTS COBE CARDIOVASCULAR, INC.
K033641 11/20/2003 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 COBE CARDIOVASCULAR, INC.
K994209 12/14/1999 STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP COBE CARDIOVASCULAR, INC.
K984456 12/15/1998 COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC.
K974812 12/23/1997 COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR COBE CARDIOVASCULAR, INC.
K994389 12/28/1999 COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED COBE CARDIOVASCULAR, INC.
K004046 12/29/2000 COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC.
K974897 12/31/1997 COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET COBE CARDIOVASCULAR, INC.
K960974 03/11/1996 COBE CENTURY PERFUSION PUMP COBE CARDIOVASCULAR, INC.
K971669 05/06/1997 COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR COBE CARDIOVASCULAR, INC.
K962689 07/11/1996 COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY PROGRAM (PRP) COBE CARDIOVASCULAR, INC.
K963518 09/03/1996 COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR COBE CARDIOVASCULAR, INC.
K964043 10/09/1996 COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS COBE CARDIOVASCULAR, INC.
K021830 06/04/2002 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM COBE CARDIOVASCULAR, INC.
K013480 10/19/2001 COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR COBE CARDIOVASCULAR, INC.


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