ClearanceBrief
510(k) K182916 ยท MJN Catheter, Intravascular Occluding, Temporary

Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr

ApplicantLemaitre Vascular, Burlington MA, US
DecisionSubstantially Equivalent, Nov 16, 2018
ReceivedOct 18, 2018
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K182916

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.