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 Oxygenator, Cardiopulmonary Bypass
510(k) Number K250821
Device Name Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
Applicant
Eurosets Srl
Strada Statale 12, N°143
Medolla,  IT 41036
Applicant Contact Katia Vescovini
Correspondent
Accurate Consultants, Inc.
3234 Ibis St.
San Diego,  CA  92103
Correspondent Contact Sebastian Feye
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTN   DTR  
Date Received03/18/2025
Decision Date 12/12/2025
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
-
-