|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
mars monitor itc us, mars treatment kit type 1116/1 - x-mars us, prismaflex control unit
|
GAMBRO RENAL PRODUCTS, INC.
|
K133807 |
03/26/2014
|
prismaflex system 7.10
|
GAMBRO RENAL PRODUCTS, INC.
|
K131516 |
01/03/2014
|
revaclear 300 dialyzer, revaclear 400 dialyzer
|
GAMBRO RENAL PRODUCTS, INC.
|
K130039 |
05/02/2013
|
prismaflex
|
GAMBRO RENAL PRODUCTS, INC.
|
K110823 |
06/17/2011
|
phoenix hemodialysis delivery system
|
GAMBRO RENAL PRODUCTS, INC.
|
K103832 |
05/20/2011
|
prismaflex m150 set
|
GAMBRO RENAL PRODUCTS, INC.
|
K080519 |
06/13/2008
|
gambro polyflux hemodialyzer, model: hd-c4 small
|
GAMBRO RENAL PRODUCTS, INC.
|
K072232 |
09/07/2007
|
prisma m10 pre set
|
GAMBRO RENAL PRODUCTS, INC.
|
K063183 |
02/15/2007
|
prisma system r03.10a
|
GAMBRO RENAL PRODUCTS
|
K062090 |
10/18/2006
|
gambro polyflux hd-c4 capillary dialyzer/filter for single use
|
GAMBRO RENAL PRODUCTS
|
K060195 |
04/24/2006
|