ClearanceBrief
510(k) K060651 ยท NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

PROXIS SYSTEM, MODEL EPS101

ApplicantSt Jude Medical, Maple Grove MN, US
DecisionSubstantially Equivalent, Sep 13, 2006
ReceivedMar 13, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060651

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.