510(k) K233335 · KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Tablo® Hemodialysis System
| Applicant | Outset Medical, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Dec 5, 2023 |
| Received | Sep 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2024 | Outset Medical, Inc. Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or witho Open, Classified |
KDI | None listed |
| Jun 14, 2024 | Outset Medical, Inc. TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodial Open, Classified |
KDI | None listed |
| Apr 12, 2024 | Outset Medical, Inc. Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.