SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K030409
Device Name SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
Applicant
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, 
FL 
33014

Applicant Contact sam mirza
Correspondent
CORDIS CORP.
14201 n.w. 60th ave.
miami lakes, 
FL 
33014

Correspodent Contact sam mirza
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 02/07/2003
Decision Date 03/10/2003
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