ClearanceBrief
510(k) K242319 · QEW Peripheral Mechanical Thrombectomy With Aspiration

Indigo® Aspiration System – Aspiration Catheter 6X

ApplicantPenumbra, Inc., Alameda CA, US
DecisionSubstantially Equivalent, Sep 3, 2024
ReceivedAug 5, 2024
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K242319

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.