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 catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K192493
Device Name BD Cathena (TM) Safety IV Catheter
Applicant
Becton, Dickinson Infusion Therapy Systems, Inc.
9450 South State Street
Sandy,  UT  84070
Applicant Contact Henry Boland
Correspondent
Becton, Dickinson Infusion Therapy Systems, Inc.
9450 South State Street
Sandy,  UT  84070
Correspondent Contact Henry Boland
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/11/2019
Decision Date 01/24/2020
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
-
-