MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K024048
Device Name MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
Original Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, 
MN 
55311

Original Contact todd kornmann
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 12/09/2002
Decision Date 01/06/2003
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