510(k) Report

Devices descending from K160482

1 later device reach t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—