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 Set, Administration, Intravascular
510(k) Number K193088
Device Name MaxZero Extension Sets with Needle-Free Connector(s)
Applicant
Carefusion, Inc.
120 S State College Blvd., Suite 100
Brea,  CA  92821
Applicant Contact Viviana Lai
Correspondent
Carefusion, Inc.
120 S State College Blvd., Suite 100
Brea,  CA  92821
Correspondent Contact Nesli Karakaya
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/06/2019
Decision Date 10/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-