ClearanceBrief
510(k) K860497 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

CAROTID BALLOON SHUNT

ApplicantImodex, Inc., St. Clair Shores MI, US
DecisionSubstantially Equivalent, May 28, 1986
ReceivedFeb 10, 1986
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K860497

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.