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 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K232132
Device Name LifeSPARC System
Applicant
Cardiacassist, Inc.
620 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact Arielle Drummond
Correspondent
Cardiacassist, Inc.
620 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact Arielle Drummond
Regulation Number870.4360
Classification Product Code
KFM  
Subsequent Product Code
DWA  
Date Received07/18/2023
Decision Date 08/03/2023
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
-
-