FDA 510(k) Applications Submitted by GAMBRO RENAL PRODUCTS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040255 |
02/04/2004 |
POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE |
GAMBRO RENAL PRODUCTS, INC. |
| K063183 |
10/19/2006 |
PRISMA M10 PRE SET |
GAMBRO RENAL PRODUCTS, INC. |
| K130039 |
01/07/2013 |
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER |
GAMBRO RENAL PRODUCTS, INC. |
| K100364 |
02/12/2010 |
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 |
GAMBRO RENAL PRODUCTS, INC. |
| K100451 |
02/17/2010 |
GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 |
GAMBRO RENAL PRODUCTS, INC. |
| K080519 |
02/25/2008 |
PRISMAFLEX M150 SET |
GAMBRO RENAL PRODUCTS, INC. |
| K110823 |
03/24/2011 |
PRISMAFLEX |
GAMBRO RENAL PRODUCTS, INC. |
| K131516 |
05/28/2013 |
PRISMAFLEX SYSTEM 7.10 |
GAMBRO RENAL PRODUCTS, INC. |
| K072232 |
08/10/2007 |
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL |
GAMBRO RENAL PRODUCTS, INC. |
| K113313 |
11/09/2011 |
MOLECULAR ADSORBENT RECIRCULATING(MARS) |
GAMBRO RENAL PRODUCTS, INC. |
| K093608 |
11/20/2009 |
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H |
GAMBRO RENAL PRODUCTS, INC. |
| K133807 |
12/16/2013 |
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT |
GAMBRO RENAL PRODUCTS, INC. |
| K103832 |
12/30/2010 |
PHOENIX HEMODIALYSIS DELIVERY SYSTEM |
GAMBRO RENAL PRODUCTS, INC. |
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