NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
FDA 510(k) clearance K232803 · decided 2024-03-14
Clearance details
- K-number
- K232803
- Device name
- NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
- Applicant
- Nxstage Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-12
- Decision date
- 2024-03-14
- Days to decision
- 184 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
No recalls on record reference this clearance.