FDA 510(k) K093679, AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip, by AtriCure, Inc.

Device Classification Name: Clip, Implantable
510(k) Number: K093679
Device Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
Applicant: AtriCure, Inc.
Regulation Number: 878.43
Classification Product Code: FZP
Date Received: 2009-11-27
Decision Date: 2010-06-10
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 3,764
Fully redacted pages: 3,581
Content pages: 183