Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
510(k) Number K234151
Device Name Isolator Synergy EnCapture Ablation System (EMH)
Applicant
AtriCure, Inc.
7555 Innovation Way
West Chester,  OH  45040
Applicant Contact Dominique Neisz
Correspondent
AtriCure, Inc.
7555 Innovation Way
West Chester,  OH  45040
Correspondent Contact Dominique Neisz
Regulation Number878.4400
Classification Product Code
OCL  
Date Received12/29/2023
Decision Date 08/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-