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 Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K181446
Device Name Bard Power-Injectable Implantable Ports (PowerPorts®)
Applicant
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Jeff Peterson
Correspondent
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Jeff Peterson
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/01/2018
Decision Date 07/08/2019
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
-
-