510(k) Report

Devices descending from K963698

2 later devices reach CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4 through their predicates, nearest generation first.

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