NXSTAGE SYSTEM ONE
FDA 510(k) clearance K030470 · decided 2003-07-07
Clearance details
- K-number
- K030470
- Device name
- NXSTAGE SYSTEM ONE
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-12
- Decision date
- 2003-07-07
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- FII
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lawrence, MA, US
- Third-party review
- Yes
- 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 |
|---|---|---|
| GAMBRO MULTIPURPOSE SYSTEM MPS-10 (K881270) | Gambro, Inc. | 1988-08-24 |
| HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (K872364) | Travenol Laboratories, S.A. | 1987-10-13 |
| HEMOFILTRATION SYSTEM 10 (K862716) | Gambro, Inc. | 1986-09-09 |
| COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA (K822386) | Hospal Medical Corp. | 1982-10-06 |
Recalls involving this device
No recalls on record reference this clearance.