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 Heat-Exchanger, Cardiopulmonary Bypass
510(k) Number K240190
Device Name MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
Applicant
Medtronic
8200 Coral Sea St. NE
Mounds View,  MN  55040
Applicant Contact Kaitlin Cady
Correspondent
Medtronic
8200 Coral Sea St. NE
Mounds View,  MN  55040
Correspondent Contact Kaitlin Cady
Regulation Number870.4240
Classification Product Code
DTR  
Subsequent Product Code
DWF  
Date Received01/24/2024
Decision Date 02/23/2024
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
-
-