510(k) Report

Devices descending from K192125

1 later device reach Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—