WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM

Device Classification Name

catheter, biliary, diagnostic

510(k) Number K033909
Device Name WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
Applicant
ABBOTT LABORATORIES
400 saginaw dr.
redwood city, 
CA 
94063

Applicant Contact joanna kuskowski
Correspondent
ABBOTT LABORATORIES
400 saginaw dr.
redwood city, 
CA 
94063

Correspodent Contact joanna kuskowski
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 12/17/2003
Decision Date 02/17/2004
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