ClearanceBrief
510(k) K070558 ยท EZL Catheter, Retention Type, Balloon

BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS

ApplicantC.R. Bard, Inc., Covington GA, US
DecisionSubstantially Equivalent, Dec 7, 2007
ReceivedFeb 27, 2007
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K070558

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.