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 K002143
Device Name DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
Applicant
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054 -2807
Applicant Contact SUSAN SILAVIN, PH.D.
Correspondent
Guidant Corp.
3200 Lakeside Dr.
Santa Clara,  CA  95054 -2807
Correspondent Contact SUSAN SILAVIN, PH.D.
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/17/2000
Decision Date 10/12/2000
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-