MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K021345
Device Name MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
Original Applicant
CORDIS CORP.
7 powder horn dr.
warren, 
NJ 
07059

Original Contact karen wilk
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 04/29/2002
Decision Date 06/28/2002
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