PROTEGE GPS SELF-EXPANDING NITINOL STENT


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K050725
Device Name PROTEGE GPS SELF-EXPANDING NITINOL STENT
Applicant
EV3 CORPORATION
4600 nathan ln. north
plymouth, 
MN 
55442 -2920

Applicant Contact glen d smythe
Correspondent
EV3 CORPORATION
4600 nathan ln. north
plymouth, 
MN 
55442 -2920

Correspodent Contact glen d smythe
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 03/21/2005
Decision Date 04/20/2005
Decision

substantially equivalent

(SESE)

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