MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K022026
Device Name MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
Original Applicant
MEDTRONIC AVE, INC.
2170-a northpoint prkwy
santa rosa, 
CA 
95407

Original Contact kevin drisko
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 06/21/2002
Decision Date 07/19/2002
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