510(k) Report

Devices descending from K130521

3 later devices reach Isolator Linear Pen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163408Isolator Multifunctional Linear PenAtriCure, Inc.20172—
+2K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear PenAtriCure, Inc.20191—
+3K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—