ClearanceBrief
510(k) K002612 ยท EZL Catheter, Retention Type, Balloon

BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON

ApplicantC.R. Bard, Inc., Covington GA, US
DecisionSubstantially Equivalent, Sep 3, 2002
ReceivedAug 21, 2000
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K002612

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.