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Cobe Cardiovascular, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGMarch 8, 2005
K042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMNovember 19, 2004
K040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERFebruary 26, 2004
K033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800December 11, 2003
K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700March 6, 2003
K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEMJuly 2, 2002
K011835COBE REVOLUTIONFebruary 12, 2002
K013480COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATORNovember 16, 2001
K012763SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEMNovember 15, 2001
K001509STOCKERT V172 SERIES VENOUS FEMORAL CANNULAEOctober 26, 2001
K012898MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEMSeptember 17, 2001
K004046COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS REApril 26, 2001
K002493DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL November 30, 2000
K002591COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRSeptember 13, 2000
K994209STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIPJune 14, 2000
K000255COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATORApril 25, 2000
K994389COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTEREDMarch 27, 2000
K993001COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTEREDDecember 3, 1999
K991452COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOROctober 7, 1999
K991986COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTIONSeptember 9, 1999