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 stents, drains and dilators for the biliary ducts
510(k) Number K063532
Device Name BARD E LUMINEXX BILIARY STENT
Applicant
BARD PERIPHERAL VASCULAR, INC.
P.O. BOX 1740
TEMPE,  AZ  85280 -1740
Applicant Contact LINDSAY K PACK
Correspondent
BARD PERIPHERAL VASCULAR, INC.
P.O. BOX 1740
TEMPE,  AZ  85280 -1740
Correspondent Contact LINDSAY K PACK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/22/2006
Decision Date 05/30/2008
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-