FDA 510(k) Applications Submitted by LYNN LEONARD

FDA 510(k) Number Submission Date Device Name Applicant
K993001 09/07/1999 COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED COBE CARDIOVASCULAR, INC.
K990103 01/12/1999 MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE SORIN BIOMEDICAL, 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.
K960456 01/30/1996 DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY DENVER BIOMATERIALS, INC.
K010478 02/20/2001 DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR DIDECO
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.
K971753 05/12/1997 DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 DENVER BIOMATERIALS, 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.
K001961 06/27/2000 STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE STOECKERT INSTRUMENTE
K982406 07/10/1998 COBE VACUUM RELIEF CHECK VALVE COBE CARDIOVASCULAR, INC.
K022280 07/15/2002 STOCKERT CORONARY PERFUSION CANNULAE STOCKERT INSTRUMENTE GMBH
K962814 07/19/1996 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER BIOMATERIALS, 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.
K023622 10/29/2002 STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 STOCKERT INSTRUMENTE GMBH
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.


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