ClearanceBrief
510(k) K021142 ยท EZL Catheter, Retention Type, Balloon

ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865

ApplicantFortune Medical Instrument Corp., Taipei Hsien, TW
DecisionSubstantially Equivalent, Oct 1, 2002
ReceivedApr 9, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K021142

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.