INTRASTENT


Device Classification Name

catheter, biliary, diagnostic

510(k) Number K991929
Device Name INTRASTENT
Applicant
INTRATHERAPEUTICS, INC.
651 campus dr.
st. paul, 
MN 
55112

Applicant Contact cathy yohnk
Correspondent
INTRATHERAPEUTICS, INC.
651 campus dr.
st. paul, 
MN 
55112

Correspodent Contact cathy yohnk
Regulation Number 876.5010
Classification Product Code
FGE  
Date Received 06/08/1999
Decision Date 08/04/1999
Decision

se – with limitations

(SESU)
Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology
summary

summary

Type Special
Reviewed by Third Party No
Combination Product

No