5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K072301
Device Name 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
Applicant
EV3 INC.
4600 nathan ln. north
plymouth, 
MN 
55442 -2920

Applicant Contact david worrell
Correspondent
EV3 INC.
4600 nathan ln. north
plymouth, 
MN 
55442 -2920

Correspodent Contact david worrell
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 08/17/2007
Decision Date 03/18/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No