ClearanceBrief
510(k) K261492 ยท DYB Introducer, Catheter

FieldFlex Steerable Sheath

ApplicantCenterPoint Systems, LLC, West Valley City UT, US
DecisionSubstantially Equivalent, Jun 5, 2026
ReceivedMay 6, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K261492

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.