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 Computer, Diagnostic, Programmable
510(k) Number K251234
Device Name EnSite™ X EP System
Applicant
Abbott Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117 -9913
Applicant Contact Hailey Christain
Correspondent
Abbott Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117 -9913
Correspondent Contact Hailey Christain
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/22/2025
Decision Date 07/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-