510(k) K153449 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
2008K2 Hemodialysis Machine
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Apr 26, 2016 |
| Received | Nov 30, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153449
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2020 | Fresenius Medical Care Holdings, Inc. Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery E Terminated |
KDI | None listed |
| Mar 20, 2018 | Fresenius Medical Care Renal Therapies Group, LLC 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861 Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.