ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM

Device Classification Name

catheter, biliary, diagnostic

510(k) Number K033393
Device Name ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
Applicant
GUIDANT CORP.
3200 lakeside dr.
santa clara, 
CA 
95054

Applicant Contact kelly pike
Correspondent
GUIDANT CORP.
3200 lakeside dr.
santa clara, 
CA 
95054

Correspodent Contact kelly pike
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 10/23/2003
Decision Date 11/10/2003
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

Recalls CDRH Recalls