NXSTAGE PUREFLOW SL
FDA 510(k) clearance K080919 · decided 2008-10-15
Clearance details
- K-number
- K080919
- Device name
- NXSTAGE PUREFLOW SL
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-01
- Decision date
- 2008-10-15
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- FKR
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lawrence, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| NXSTAGE PUREFLOW SL (K140571) | Nxstage Medical, Inc. | 2014-05-15 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFl recall (Z-0826-2012) | NxStage Medical, Inc. | 2012-01-20 |