INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K003040
Device Name INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Original Applicant
INTRATHERAPEUTICS, INC.
651 campus dr.
st. paul, 
MN 
55112

Original Contact maria e brittle
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 09/29/2000
Decision Date 12/28/2000
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

Type Traditional
Reviewed by Third Party No

Combination Product

No