ClearanceBrief
510(k) K211061 ยท QEY Mechanical Thrombolysis Catheter

BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)

ApplicantThrombolex, Inc., New Britain PA, US
DecisionSubstantially Equivalent, Jun 10, 2021
ReceivedApr 9, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K211061

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.