510(k) K201207 ยท KOC Accessories, Blood Circuit, Hemodialysis
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Sep 18, 2020 |
| Received | May 5, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201207
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.