Medical Device Manufacturer · US , Arvada , CO

Cobe Cardiovascular, Inc. - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1992
43
Total
43
Cleared
0
Denied
43 devices
26-43 of 43
Cleared Aug 24, 1998
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K980786 · DTN
Cardiovascular · 175d
Cleared Jun 01, 1998
COBE(R) CML DUO(R) WITH SMART(TM) SURFACE MODIFIED MEMBRANCE OXYGENATOR
K974812 · DTZ
Cardiovascular · 160d
Cleared Mar 31, 1998
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
K974897 · CAC
Anesthesiology · 90d
Cleared Jan 27, 1998
COBE OXYGENATOR PRODUCTS
K974085 · DTZ
Cardiovascular · 90d
Cleared Dec 08, 1997
COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
K963518 · DTZ
Cardiovascular · 461d
Cleared Nov 03, 1997
STANDARD VOLUME PROCESSING SET FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE...
K973627 · CAC
Anesthesiology · 40d
Cleared Sep 29, 1997
COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
K964043 · DTZ
Cardiovascular · 355d
Cleared Jul 23, 1997
COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR
K971669 · DTN
Cardiovascular · 78d
Cleared Jul 14, 1997
COBE CENTURY PERFUSION PUMP
K960974 · DWB
Cardiovascular · 490d
Cleared Jan 28, 1997
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH MODIFIED PLASMA RECOVERY...
K962689 · CAC
Anesthesiology · 201d
Cleared Apr 28, 1995
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
K944267 · DTR
Cardiovascular · 239d
Cleared Jun 10, 1994
PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
K933960 · CAC
Anesthesiology · 298d
Cleared Dec 29, 1993
BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
K933625 · CAC
Anesthesiology · 163d
Cleared Nov 09, 1993
COBE CMS-FS MEMBRANE OXYGENATOR
K926467 · DTZ
Cardiovascular · 316d
Cleared Jan 05, 1993
COBE PATIENT MONITORING PRODUCTS
K921343 · DRS
Cardiovascular · 292d
Cleared Dec 03, 1992
COBE SAMPLING SITE
K922484 · DQO
Cardiovascular · 190d
Cleared Oct 01, 1992
NEW COBE CARDIOPLEGIA SYSTEM
K920312 · DTN
Cardiovascular · 252d
Cleared Jan 27, 1992
COBE BRAT SYSTEMS WITHOUT REINFUSION PROTECTION
K913773 · CAC
Anesthesiology · 157d
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