MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K023217
Device Name MODIFICATION TO 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 09/26/2002
Decision Date 10/25/2002
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

Recalls CDRH Recalls