Cobe Renal Care, Inc. - FDA 510(k) Cleared Devices
Recent clearances: GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET, COBE CENTRYSYSTEM 14 PES HEMODIALYZERS, GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cobe Renal Care, Inc. Gastroenterology & Urology ✕
14 devices
Cleared
Sep 25, 1997
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
Gastroenterology & Urology
664d
Cleared
Apr 30, 1997
COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
Gastroenterology & Urology
510d
Cleared
Apr 18, 1997
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
Gastroenterology & Urology
504d
Cleared
Feb 10, 1997
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
Gastroenterology & Urology
776d
Cleared
Feb 06, 1997
COBE HEMODYNAMIC RECIRCULATION MONITOR
Gastroenterology & Urology
531d
Cleared
Aug 14, 1996
COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
Gastroenterology & Urology
194d
Cleared
Jan 29, 1996
COBE CENTRYSYSTEM CS 200 DIALYZER
Gastroenterology & Urology
504d
Cleared
Jan 11, 1996
GAMBRO HC 14R HEMOCONCENTRATOR
Gastroenterology & Urology
295d
Cleared
Sep 15, 1995
GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS
Gastroenterology & Urology
119d
Cleared
Sep 08, 1995
GAMBRO LUNDIA 94-500 DIALYZER
Gastroenterology & Urology
289d
Cleared
Sep 08, 1995
GAMBRO LUNDIA 94-600 DIALYZER
Gastroenterology & Urology
289d
Cleared
Mar 13, 1995
GAMBRO FH 66 D HEMOFILTER
Gastroenterology & Urology
580d