INTRASTENT DOUBLESTRUT LD

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 Doublestrut Ld.

Pre-market Notification Details

Device IDK993904
510k NumberK993904
Device Name:INTRASTENT DOUBLESTRUT LD
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 Received1999-11-17
Decision Date2000-02-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821684014158 K993904 000
00821684014011 K993904 000
00821684014028 K993904 000
00821684014035 K993904 000
00821684014042 K993904 000
00821684014110 K993904 000
00821684014127 K993904 000
00821684014134 K993904 000
00821684014141 K993904 000
00821684014004 K993904 000

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