Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
FDA 510(k) clearance K232776 · decided 2024-05-03
Clearance details
- K-number
- K232776
- Device name
- Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer
- Applicant
- Outset Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-11
- Decision date
- 2024-05-03
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- KDI
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN recall (Z-2150-2024) | Outset Medical, Inc. | 2024-06-14 |