510(k) Report

Devices descending from K896742

3 later devices reach Focus J81F, J83F, J41F, J43F Pacing Leads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972574Stela Model UJ45 Pacing LeadsEla Medical, Inc.19981—
+1K963738Stela Model BJ44 and BJ45 Pacing LeadsEla Medical, Inc.19970—
+2K993448Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…Ela Medical, Inc.20000—