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 Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
510(k) Number K234118
Device Name CentriMag™ Acute Circulatory Support System
Applicant
Abbott Medical
6035 Stoneridge Dr. Pleasanton
Pleasanton,  CA  94588
Applicant Contact Bendre Ketaki
Correspondent
Abbott Medical
6035 Stoneridge Dr. Pleasanton
Pleasanton,  CA  94588
Correspondent Contact Manas Lele
Regulation Number870.4100
Classification Product Code
QNR  
Subsequent Product Codes
DWA   KFM  
Date Received12/28/2023
Decision Date 01/26/2024
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
-
-