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

35 devices

26-35 of 35

Cleared Jan 27, 1998

COBE OXYGENATOR PRODUCTS

Cardiovascular · 90d

Cleared Dec 08, 1997

COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR

Cardiovascular · 461d

Cleared Sep 29, 1997

COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS

Cardiovascular · 355d

Cleared Jul 23, 1997

COBE HVR 4000 FILTERED AND NONFILTERED HARDSHELL VENOUS RESERVOIR

Cardiovascular · 78d

Cleared Jul 14, 1997

COBE CENTURY PERFUSION PUMP

Cardiovascular · 490d

Cleared Apr 28, 1995

HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA

Cardiovascular · 239d

Cleared Nov 09, 1993

COBE CMS-FS MEMBRANE OXYGENATOR

Cardiovascular · 316d

Cleared Jan 05, 1993

COBE PATIENT MONITORING PRODUCTS

Cardiovascular · 292d

Cleared Dec 03, 1992

COBE SAMPLING SITE

Cardiovascular · 190d

Cleared Oct 01, 1992

NEW COBE CARDIOPLEGIA SYSTEM

Cardiovascular · 252d