EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K024303
Device Name EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
Original Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine, 
CA 
92614

Original Contact kavin drisko
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 12/24/2002
Decision Date 07/03/2003
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No