510(k) K030497 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES
| Applicant | Fresenius Medical Care, Lexington MA, US |
| Decision | Substantially Equivalent, May 20, 2003 |
| Received | Feb 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030497
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL
Catalog Number: OFD2201-3B for hemodialysis Terminated |
KPO | None listed |
| Oct 9, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL
Catalog Number: OFD2251-3B for hemodialysis Terminated |
KPO | None listed |
| Oct 9, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL
Catalog Number: OFD3251-3B for hemodialysis Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL
Catalog Number: OFD2251-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and chronic renal Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL
Catalog Number: OFD2201-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and ch Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL
Catalog Number: OFD3251-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and ch Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL
Catalog Number: OFD2231-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and c Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL
Catalog Number: OFD1201-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and ch Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL
Catalog Number: OFD2225-3B
Product Usage:
GranuFlo is indicated in the treatment of acute a Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL
Catalog Number: OFD2223-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL
Catalog Number: OFD3201-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and Terminated |
KPO | None listed |
| Jan 17, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL
Catalog Number: OFD2325-3B
Product Usage:
GranuFlo is indicated in the treatment of acute and Terminated |
KPO | None listed |
| Jun 25, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius NaturaLyte Liquid Acid Concentrate
Product Codes:
08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1, Terminated |
KPO | None listed |
| Jun 25, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo (powder) Acid Concentrate
Product Codes:
OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3 Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.