Gambro Renal Products - FDA 510(k) Cleared Devices

Cleared May 25, 2012

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

K120333 · KPO

Gastroenterology & Urology · 112d

Cleared Feb 04, 2008

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY

K072908 · KPO

Gastroenterology & Urology · 115d

Cleared Oct 12, 2007

GAMBRO CARTRIDGE BLOOD SETS

K070414 · FJK

Gastroenterology & Urology · 242d

Cleared Jan 30, 2007

GAMBRO QUICKSET BLOODLINES

K063290 · FJK

Gastroenterology & Urology · 90d

Cleared Oct 18, 2006

PRISMA SYSTEM R03.10A

K062090 · KDI

Gastroenterology & Urology · 86d

Cleared Apr 24, 2006

GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE

K060195 · KDI

Gastroenterology & Urology · 89d

Cleared Dec 09, 2005

GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

K051520 · KDI

Gastroenterology & Urology · 184d

Cleared Nov 02, 2005

MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

K052253 · KPO

Gastroenterology & Urology · 76d

Cleared May 27, 2005

MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

K033262 · FLD

Gastroenterology & Urology · 596d

Cleared May 27, 2005

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE,...

K043342 · FJI

Gastroenterology & Urology · 172d

Cleared Mar 09, 2005

WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K042797 · FIP

Gastroenterology & Urology · 152d

Cleared Jan 06, 2005

GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS

K042938 · KDI

Gastroenterology & Urology · 73d