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 K211830
Device Name LifeSPARC System
Applicant
Cardiacassist, Inc.
620 Alpha Dr. Suite 2
Pittsburg,  PA  15238
Applicant Contact Megan Walsh
Correspondent
Cardiacassist, Inc.
620 Alpha Dr. Suite 2
Pittsburg,  PA  15238
Correspondent Contact Arielle Drummond
Regulation Number870.4100
Classification Product Code
QNR  
Date Received06/14/2021
Decision Date 11/15/2022
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
-
-