ClearanceBrief
510(k) K130872 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

CARDIOCEL

ApplicantCelxcel Pty, Ltd., Rockville MD, US
DecisionSubstantially Equivalent, Jan 30, 2014
ReceivedMar 29, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K130872

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.