5008X Hemodialysis System
FDA 510(k) clearance K231534 · decided 2024-02-02
Clearance details
- K-number
- K231534
- Device name
- 5008X Hemodialysis System
- Applicant
- Fresenius Medical Care
- Decision
- Substantially Equivalent
- Date received
- 2023-05-30
- Decision date
- 2024-02-02
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. recall (Z-1992-2025) | Fresenius Medical Care Holdings, Inc. | 2025-06-18 |