ClearanceBrief
510(k) K003454 ยท DTD Pacemaker Lead Adaptor

A1-CS-SB Y-ADAPTER, MODEL 124 871

ApplicantBiotronik, Inc., Lake Oswego OR, US
DecisionSubstantially Equivalent - Subject to Tracking Reg., Jan 18, 2001
ReceivedNov 7, 2000
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K003454

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.