ClearanceBrief
510(k) K192283 ยท DRE Dilator, Vessel, For Percutaneous Catheterization

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator

ApplicantMedron, LLC, Salt Lake City UT, US
DecisionSubstantially Equivalent, May 6, 2020
ReceivedAug 22, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K192283

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.