DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K021824
Device Name DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
Original Applicant
GUIDANT CORP.
1525 o’brien dr.
menlo park, 
CA 
94025

Original Contact martha murari
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 06/04/2002
Decision Date 07/02/2002
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