Device Listing 1114937658

Listing Summary#

Listing key
1114937658
Premarket submission
K221358
Device
Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
Applicant
AtriCure, Inc.
Product code
OCL
Decision date
2022-12-30