ClearanceBrief
510(k) K000004 ยท DYB Introducer, Catheter

ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

ApplicantDaig Corp., Minnetonka MN, US
DecisionSubstantially Equivalent, Nov 29, 2000
ReceivedJan 3, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K000004

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.