INTRASTENT II

Stents, Drains And Dilators For The Biliary Ducts

INTRATHERAPEUTICS, INC.

The following data is part of a premarket notification filed by Intratherapeutics, Inc. with the FDA for Intrastent Ii.

Pre-market Notification Details

Device IDK990592
510k NumberK990592
Device Name:INTRASTENT II
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul,  MN  55112
ContactCathy Yohnk
CorrespondentCathy Yohnk
INTRATHERAPEUTICS, INC. 651 CAMPUS DR. St. Paul,  MN  55112
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-24
Decision Date1999-09-01

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