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 K022026
Device Name MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
Applicant
Medtronic Ave, Inc.
2170-A Northpoint Prkwy
Santa Rosa,  CA  95407
Applicant Contact KEVIN DRISKO
Correspondent
Medtronic Ave, Inc.
2170-A Northpoint Prkwy
Santa Rosa,  CA  95407
Correspondent Contact KEVIN DRISKO
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/21/2002
Decision Date 07/19/2002
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-