Medical Device Manufacturer · US , Lakewood , CO

Gambro Renal Products

24 submissions · 23 cleared · Since 2000
24
Total
23
Cleared
0
Denied

Gambro Renal Products — FDA 510(k) Submissions

Gambro Renal Products has submitted 24 FDA 510(k) premarket notifications since 2000, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Dialysate Concentrate For Hemodialysis (liquid Or Powder), Subsystem, Water Purification, Set, Tubing, Blood, With And Without Anti-regurgitation Valve, Hemodialyzer, Re-use, High Flux . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
K120333 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
May 2012 112d
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
K072908 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Feb 2008 115d
GAMBRO CARTRIDGE BLOOD SETS
K070414 · FJK Set, Tubing, Blood, With... · Gastroenterology & Urology
Oct 2007 242d
GAMBRO QUICKSET BLOODLINES
K063290 · FJK Set, Tubing, Blood, With... · Gastroenterology & Urology
Jan 2007 90d
PRISMA SYSTEM R03.10A
K062090 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 2006 86d
GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
K060195 · KDI Dialyzer, High... · Gastroenterology & Urology
Apr 2006 89d
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
K051520 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 2005 184d
MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K052253 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Nov 2005 76d
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
K033262 · FLD Apparatus, Hemoperfusion,... · Gastroenterology & Urology
May 2005 596d
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
K043342 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
May 2005 172d
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K042797 · FIP Subsystem, Water... · Gastroenterology & Urology
Mar 2005 152d
GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
K042938 · KDI Dialyzer, High... · Gastroenterology & Urology
Jan 2005 73d
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
K040301 · MPB Catheter, Hemodialysis,... · Gastroenterology & Urology
Nov 2004 266d
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
K041005 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 2004 171d
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
K023615 · MSF Hemodialyzer, Re-use,... · Gastroenterology & Urology
May 2003 190d
PRISMA SYSTEM
K010805 · KDI Dialyzer, High... · Gastroenterology & Urology
Aug 2002 508d
PRISMASATE
K013448 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Jan 2002 90d
BICART
K013724 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Jan 2002 60d
DIACLEAR ULTRAFILTER
K003957 · FIP Subsystem, Water... · Gastroenterology & Urology
Nov 2001 315d
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
K011221 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 2001 194d
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
K010985 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 2001 191d
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Aug 2001 90d
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R
K010667 · KDI Dialyzer, High... · Gastroenterology & Urology
Jun 2001 90d
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
K001156 · KDI Dialyzer, High... · Gastroenterology & Urology
Jul 2000 88d
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