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 K012056
Device Name CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
Applicant
CORDIS EUROPA N.V.
7 POWDER HORN DR.
WARREN,  NJ  07059
Applicant Contact CHUCK RYAN
Correspondent
CORDIS EUROPA N.V.
7 POWDER HORN DR.
WARREN,  NJ  07059
Correspondent Contact CHUCK RYAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/02/2001
Decision Date 08/01/2001
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
-
-