510(k) Report

Devices descending from K122611

3 later devices reach Coolrail Linear Pen Model Mcri through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183065Coolrail Linear PenAtriCure, Inc.20182—
+2K190587Coolrail Linear PenAtriCure, Inc.20191—
+3K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—