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 K050310
Device Name BARDPORT TITANIUM PORTS
Applicant
BARD ACCESS SYSTEMS, INC.
5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY,  UT  84116
Applicant Contact MICHAELA RIVKOWICH
Correspondent
BARD ACCESS SYSTEMS, INC.
5425 WEST AMELIA EARNHART DR.
SALT LAKE CITY,  UT  84116
Correspondent Contact MICHAELA RIVKOWICH
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/08/2005
Decision Date 04/18/2005
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
Recalls CDRH Recalls
-
-