ClearanceBrief
510(k) K031948 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16

ApplicantPm Devices, Inc., Richmond, Bc, CA
DecisionSubstantially Equivalent, Sep 16, 2003
ReceivedJun 24, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K031948

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.