ClearanceBrief
510(k) K111972 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF

ApplicantMedtronic, Inc., Minneapolis MN, US
DecisionSubstantially Equivalent, Jul 27, 2011
ReceivedJul 11, 2011
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K111972

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.