ClearanceBrief
510(k) K202821 ยท QEW Peripheral Mechanical Thrombectomy With Aspiration

Indigo Aspiration System - Aspiration Catheter 12 and Separator 12

ApplicantPenumbra, Inc., Alameda CA, US
DecisionSubstantially Equivalent, Nov 18, 2020
ReceivedSep 24, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K202821

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.