ClearanceBrief
510(k) K260942 ยท DYB Introducer, Catheter

AuST Steerable Sheath

ApplicantCenterPoint Systems, LLC, West Valley City UT, US
DecisionSubstantially Equivalent, Apr 7, 2026
ReceivedMar 20, 2026
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K260942

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.