510(k) Report

Devices descending from K923621

3 later devices reach External Demand Pacemaker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033130Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse GeneratorOsypka Medical, Inc.20030—
+1K022939Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and…Osypka Medical, Inc.20021—
+1K020896Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085…Osypka Medical, Inc.200222