• 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 K200266
Device Name BD Centro Vena Acute Central Line (7 French Dual Lumen)
Applicant
Bard Access Systems, Inc. (Bard has joined BD)
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Breanna Casados
Correspondent
Bard Access Systems, Inc. (Bard has joined BD)
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Breanna Casados
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/03/2020
Decision Date 04/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-