ClearanceBrief
510(k) K183608 ยท MOF Guide, Wire, Catheter, Neurovasculature

Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile

ApplicantScientia Vascular, LLC, West Valley City UT, US
DecisionSubstantially Equivalent, Mar 22, 2019
ReceivedDec 26, 2018
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K183608

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.