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 K130981
Device Name FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
Applicant
Cordis Corp.
6500 Paseo Padre Pkwy.
Fremont,  CA  94555
Applicant Contact KIM FONDA
Correspondent
Cordis Corp.
6500 Paseo Padre Pkwy.
Fremont,  CA  94555
Correspondent Contact KIM FONDA
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/09/2013
Decision Date 03/12/2014
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-