FLEXIMA BILIARY CATHETER


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K023870
Device Name FLEXIMA BILIARY CATHETER
Original Applicant
BOSTON SCIENTIFIC/MEDI-TECH
one boston scientific place
natick, 
MA 
01760 -1537

Original Contact nicholas condakes
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 11/20/2002
Decision Date 12/20/2002
Decision

substantially equivalent

(SESE)

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