510(k) K140571 ยท FKR Subsystem, Proportioning
NXSTAGE PUREFLOW SL
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, May 15, 2014 |
| Received | Mar 6, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140571
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2018 | NxStage Medical, Inc. NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 U Terminated |
FKR | None listed |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-301
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 100, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | None listed |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-302
Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100,
Batch Size (lite Terminated |
FKR | None listed |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-303
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m
Chloride 100m, Glucose (mg/dL) 100
Batch Size (liter Terminated |
FKR | None listed |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-304
Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1,
Chloride 101, Glucose (mg/dL) 100
Batch Size (liters) 6 Terminated |
FKR | None listed |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-305
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1
Chloride 100, Glucose (mg/dL) 100
Batch Size (liters) 40 Terminated |
FKR | None listed |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-306
Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1,
Chloride 101, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | None listed |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-307
Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 105, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | None listed |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-407
Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 105, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.