510(k) K101715 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
| Applicant | Fresenius Medical Care North America, Design Cente, Waltham MA, US |
| Decision | Substantially Equivalent, Dec 21, 2010 |
| Received | Jun 18, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101715
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Service Replacement 0-Ring.
Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.