510(k) Report

Devices descending from K160004

2 later devices reach Crosstella OTW through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+2K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—