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 K133110
Device Name EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
Applicant
Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Applicant Contact RENEE MITCHELL
Correspondent
Boston Scientific Corporation
ONE SCIMED PLACE
MAPLE GROVE,  MN  55311
Correspondent Contact RENEE MITCHELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/30/2013
Decision Date 07/02/2014
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
-
-