NXSTAGE SYSTEM ONE
FDA 510(k) clearance K050525 · decided 2005-06-24
Clearance details
- K-number
- K050525
- Device name
- NXSTAGE SYSTEM ONE
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-02
- Decision date
- 2005-06-24
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lawrence, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NxStage Cartridge Express, CAR-170, for hemodialysis. recall (Z-1228-2007) | NxStage Medical, Inc. | 2007-09-20 |