NxStage System One
FDA 510(k) clearance K150472 · decided 2015-06-04
Clearance details
- K-number
- K150472
- Device name
- NxStage System One
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-23
- Decision date
- 2015-06-04
- Days to decision
- 101 days
- Clearance type
- Special
- Product code
- ODN
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NXSTAGE SYSTEM ONE (K141752) | Nxstage Medical, Inc. | 2014-12-19 |
Recalls involving this device
No recalls on record reference this clearance.