ClearanceBrief
510(k) K230632 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

VersiHD with GuideMe software

ApplicantNxstage Medical, Inc., Lawrence MA, US
DecisionSubstantially Equivalent, Aug 11, 2023
ReceivedMar 7, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K230632

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.