FDA 510(k) Applications Submitted by GAMBRO RENAL PRODUCTS

FDA 510(k) Number Submission Date Device Name Applicant
K001156 04/10/2000 PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET GAMBRO RENAL PRODUCTS
K120333 02/03/2012 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY GAMBRO RENAL PRODUCTS
K011368 05/04/2001 DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS GAMBRO RENAL PRODUCTS
K052253 08/18/2005 MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS GAMBRO RENAL PRODUCTS
K072908 10/12/2007 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY GAMBRO RENAL PRODUCTS
K013448 10/17/2001 PRISMASATE GAMBRO RENAL PRODUCTS
K013724 11/09/2001 BICART GAMBRO RENAL PRODUCTS
K010667 03/06/2001 GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R GAMBRO RENAL PRODUCTS
K010985 04/02/2001 GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L GAMBRO RENAL PRODUCTS
K023615 10/28/2002 GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR GAMBRO RENAL PRODUCTS
K033262 10/09/2003 MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) GAMBRO RENAL PRODUCTS
K043342 12/06/2004 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR GAMBRO RENAL PRODUCTS
K042797 10/08/2004 WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS GAMBRO RENAL PRODUCTS
K010805 03/16/2001 PRISMA SYSTEM GAMBRO RENAL PRODUCTS
K011221 04/20/2001 PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET GAMBRO RENAL PRODUCTS
K003957 12/21/2000 DIACLEAR ULTRAFILTER GAMBRO RENAL PRODUCTS
K060195 01/25/2006 GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE GAMBRO RENAL PRODUCTS
K040301 02/09/2004 GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A GAMBRO RENAL PRODUCTS
K070414 02/12/2007 GAMBRO CARTRIDGE BLOOD SETS GAMBRO RENAL PRODUCTS
K041005 04/19/2004 GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS GAMBRO RENAL PRODUCTS
K051520 06/08/2005 GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H GAMBRO RENAL PRODUCTS
K062090 07/24/2006 PRISMA SYSTEM R03.10A GAMBRO RENAL PRODUCTS
K042938 10/25/2004 GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS GAMBRO RENAL PRODUCTS
K063290 11/01/2006 GAMBRO QUICKSET BLOODLINES GAMBRO RENAL PRODUCTS


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