|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
pureflow 402, pureflow 400, pureflow 406, pureflow 401, pureflow 502, pureflow 504
|
Fresenius Medical Care Renal Therapies Group, LLC
|
K233159 |
12/01/2023
|
citrasate liquid acid concentrate, naturalyte liquid acid concentrate
|
Fresenius Medical Care Renal Therapies Group, LLC
|
K212620 |
05/12/2022
|
citrasate dry acid concentrate, granuflo dry acid concentrate
|
Fresenius Medical Care Renal Therapies Group, LLC
|
K192209 |
05/08/2020
|
citrasate liquid acid concentrate, naturalyte liquid acid concentrate
|
Fresenius Medical Care Renal Therapies Group, LLC
|
K192017 |
04/24/2020
|
naturalyte dry bicarbonate concentrate (rx-10 bag), naturalyte dry bicarbonate concentrate (rx-12 bag), naturalyte dry bicarbonate concentrate (carton)
|
Fresenius Medical Care Renal Therapies Group, LLC
|
K191474 |
02/24/2020
|
bibag
|
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
|
K162716 |
05/18/2017
|
fresenius dry acid dissolution units
|
FRESENIUS MEDICAL CARE NORTH AMERICA
|
K131611 |
08/29/2013
|
2008k@home hemodialysis machine
|
FRESENIUS MEDICAL CARE NORTH AMERICA
|
K124035 |
07/03/2013
|
fresenius 2008t hemodialysis machine with bibag system
|
FRESENIUS MEDICAL CARE, NORTH AMERICA
|
K121341 |
12/06/2012
|
fresenius 2008 hemodiaysis machine with bibag system
|
FRESENIUS MEDICAL CARE, NORTH AMERICA
|
K120017 |
02/02/2012
|