SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K021898
Device Name SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Original Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, 
FL 
33014

Original Contact sam mirza
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 06/10/2002
Decision Date 08/14/2002
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