Medical Device Manufacturer · US , Arvada , CO

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

43 submissions · 43 cleared · Since 1992

Recent clearances: SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG, COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM, DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER

43

Total

43

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cobe Cardiovascular, Inc. Cardiovascular ✕

35 devices

1-12 of 35

Cleared Mar 08, 2005

SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG

Cardiovascular · 49d

Cleared Feb 26, 2004

DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER

Cardiovascular · 31d

Cleared Dec 11, 2003

SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800

Cardiovascular · 21d

Cleared Mar 06, 2003

COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700

Cardiovascular · 22d

Cleared Jul 02, 2002

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

Cardiovascular · 28d

Cleared Feb 12, 2002

COBE REVOLUTION

Cardiovascular · 245d

Cleared Nov 16, 2001

COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

Cardiovascular · 28d

Cleared Nov 15, 2001

SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

Cardiovascular · 90d

Cleared Oct 26, 2001

STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE

Cardiovascular · 529d

Cleared Sep 17, 2001

MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

Cardiovascular · 19d

Cleared Apr 26, 2001

COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000...

Cardiovascular · 118d

Cleared Nov 30, 2000

DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION)...

Cardiovascular · 108d