Medical Device Manufacturer · US , Arvada , CO

Cobe Cardiovascular, Inc.

43 submissions · 43 cleared · Since 1992
43
Total
43
Cleared
0
Denied

Cobe Cardiovascular, Inc. — FDA 510(k) Submissions

Cobe Cardiovascular, Inc. has submitted 43 FDA 510(k) premarket notifications since 1992, of which 43 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reservoir, Blood, Cardiopulmonary Bypass, Oxygenator, Cardiopulmonary Bypass, Apparatus, Autotransfusion, Heat-exchanger, Cardiopulmonary Bypass, Filter, Blood, Cardiopulmonary Bypass, Arterial Line . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
K050111 · DTN Reservoir, Blood,... · Cardiovascular
Mar 2005 49d
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
K042473 · JQC Centrifuges (micro,... · Hematology
Nov 2004 67d
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
K040184 · DTM Filter, Blood,... · Cardiovascular
Feb 2004 31d
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641 · DTN Reservoir, Blood,... · Cardiovascular
Dec 2003 21d
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · KFM Pump, Blood,... · Cardiovascular
Mar 2003 22d
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830 · DTR Heat-exchanger,... · Cardiovascular
Jul 2002 28d
COBE REVOLUTION
K011835 · KFM Pump, Blood,... · Cardiovascular
Feb 2002 245d
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K013480 · DTZ Oxygenator,... · Cardiovascular
Nov 2001 28d
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Nov 2001 90d
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
K001509 · DWF Catheter, Cannula And... · Cardiovascular
Oct 2001 529d
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · DTR Heat-exchanger,... · Cardiovascular
Sep 2001 19d
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K004046 · DTP Defoamer, Cardiopulmonary... · Cardiovascular
Apr 2001 118d
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
K002493 · DTM Filter, Blood,... · Cardiovascular
Nov 2000 108d
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · DTP Defoamer, Cardiopulmonary... · Cardiovascular
Sep 2000 23d
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
K994209 · DWF Catheter, Cannula And... · Cardiovascular
Jun 2000 183d
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K000255 · DTZ Oxygenator,... · Cardiovascular
Apr 2000 88d
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K994389 · DTN Reservoir, Blood,... · Cardiovascular
Mar 2000 90d
COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTERED
K993001 · DTN Reservoir, Blood,... · Cardiovascular
Dec 1999 87d
COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
K991452 · DTZ Oxygenator,... · Cardiovascular
Oct 1999 164d
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
K991986 · CAC Apparatus, Autotransfusion · Hematology
Sep 1999 87d
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K990239 · DTN Reservoir, Blood,... · Cardiovascular
May 1999 120d
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K984456 · DTN Reservoir, Blood,... · Cardiovascular
Jan 1999 27d
COBE SMARXT TUBING AND CONNECTORS
K981613 · DWE Tubing, Pump,... · Cardiovascular
Oct 1998 173d
COBE VACUUM RELIEF CHECK VALVE
K982406 · MJJ Cpb Check Valve,... · Cardiovascular
Oct 1998 89d
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
K982254 · DTM Filter, Blood,... · Cardiovascular
Sep 1998 76d
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