ClearanceBrief
510(k) K980487 ยท KRH Ring, Annuloplasty

CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM

ApplicantBaxter Edwards, Irvine CA, US
DecisionSubstantially Equivalent, Jul 7, 1998
ReceivedFeb 9, 1998
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K980487

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.