510(k) Report

Devices descending from K042190

2 later devices reach Model 6416 Temporary Pacing Lead System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160260Tempo Temporary Pacing LeadBiotrace Medical, Inc.20161—
+2K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.20260—