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 apparatus, autotransfusion
510(k) Number K221722
Device Name Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
Applicant
Haemonetics Corporation
125 Summer Street
Boston,  MA  02110
Applicant Contact Ergang Alexis
Correspondent
Haemonetics Corporation
125 Summer Street
Boston,  MA  02110
Correspondent Contact Ergang Alexis
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/14/2022
Decision Date 11/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-