ClearanceBrief
510(k) K003289 ยท EZL Catheter, Retention Type, Balloon

BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU

ApplicantC.R. Bard, Inc., Covington GA, US
DecisionSubstantially Equivalent, Jan 5, 2001
ReceivedOct 20, 2000
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K003289

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.