510(k) Report

Devices descending from K211311

2 later devices reach AtriCure Isolator® Synergy™ Surgical Ablation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.20240—
+1K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear…AtriCure, Inc.20220—