SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K111766
Device Name SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
Applicant
IDEV TECHNOLOGIES, INC.
253 medical center blvd
webster, 
TX 
77598

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

Correspodent Contact darene garner
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 06/23/2011
Decision Date 10/19/2011
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

Recalls CDRH Recalls