NXSTAGE SYSTEM ONE
FDA 510(k) clearance K141752 · decided 2014-12-19
Clearance details
- K-number
- K141752
- Device name
- NXSTAGE SYSTEM ONE
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-30
- Decision date
- 2014-12-19
- Days to decision
- 172 days
- Clearance type
- Traditional
- 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 (K150472) | Nxstage Medical, Inc. | 2015-06-04 |
Recalls involving this device
No recalls on record reference this clearance.