SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K111627
Device Name SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Applicant
IDEV TECHNOLOGIES, INC.
253 medical center blvd
webster, 
TX 
77598

Applicant Contact darlene garner
Correspondent
IDEV TECHNOLOGIES, INC.
253 medical center blvd
webster, 
TX 
77598

Correspodent Contact darlene garner
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 06/10/2011
Decision Date 08/21/2012
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