ClearanceBrief
510(k) K223050 ยท KRD Device, Vascular, For Promoting Embolization

AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)

ApplicantMicroVention, Inc., Aliso Viejo CA, US
DecisionSubstantially Equivalent, Dec 21, 2022
ReceivedSep 29, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K223050

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.