ClearanceBrief
510(k) K170831 ยท DYB Introducer, Catheter

EpiAccess System

ApplicantEpiep, Inc., New Haven CT, US
DecisionSubstantially Equivalent, May 9, 2017
ReceivedMar 20, 2017
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K170831

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.