OMNILINK .018 BILIARY STENT SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K011039
Device Name OMNILINK .018 BILIARY STENT SYSTEM
Original Applicant
GUIDANT CORP.
3200 lakeside dr.
santa clara, 
CA 
95054 -2807

Original Contact curtis truesdale
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 04/05/2001
Decision Date 05/08/2001
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls