Medical Device Manufacturer · US , Lakewood , CO

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

14 submissions · 14 cleared · Since 1994
14
Total
14
Cleared
0
Denied

Cobe Renal Care, Inc. has 14 FDA 510(k) cleared gastroenterology & urology devices. Based in Lakewood, US.

Historical record: 14 cleared submissions from 1994 to 1997.

Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.

14 devices
1–12 of 14
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
K955497 · KDL Set, Perfusion, Kidney, Disposable · Gastroenterology & Urology
Sep 1997 664d
COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
K955592 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System · Gastroenterology & Urology
Apr 1997 510d
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
K955487 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System · Gastroenterology & Urology
Apr 1997 504d
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K946279 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System · Gastroenterology & Urology
Feb 1997 776d
COBE HEMODYNAMIC RECIRCULATION MONITOR
K954003 · MQS System, Hemodialysis, Access Recirculation Monitoring · Gastroenterology & Urology
Feb 1997 531d
COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
K960474 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System · Gastroenterology & Urology
Aug 1996 194d
COBE CENTRYSYSTEM CS 200 DIALYZER
K944436 · FJI Dialyzer, Capillary, Hollow Fiber · Gastroenterology & Urology
Jan 1996 504d
GAMBRO HC 14R HEMOCONCENTRATOR
K951311 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System · Gastroenterology & Urology
Jan 1996 295d
GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS
K952342 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System · Gastroenterology & Urology
Sep 1995 119d
GAMBRO LUNDIA 94-500 DIALYZER
K945746 · FJI Dialyzer, Capillary, Hollow Fiber · Gastroenterology & Urology
Sep 1995 289d
GAMBRO LUNDIA 94-600 DIALYZER
K945747 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System · Gastroenterology & Urology
Sep 1995 289d
GAMBRO FH 66 D HEMOFILTER
K933883 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System · Gastroenterology & Urology
Mar 1995 580d
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