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 Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K232291
Device Name Essenz HLM, Essenz ILBM
Applicant
Livanova Deutschland, GmbH
Lindberghstr. 25
Munich,  DE 80939
Applicant Contact Florian Goetz
Correspondent
Livanova Deutschland, GmbH
Lindberghstr. 25
Munich,  DE 80939
Correspondent Contact Julie E Leslie
Regulation Number870.4220
Classification Product Code
DTQ  
Subsequent Product Code
DRY  
Date Received08/01/2023
Decision Date 08/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-