X-Suit NIR Biliary Metallic Stent

Stents, Drains And Dilators For The Biliary Ducts

MEDINOL LTD.

The following data is part of a premarket notification filed by Medinol Ltd. with the FDA for X-suit Nir Biliary Metallic Stent.

Pre-market Notification Details

Device IDK150487
510k NumberK150487
Device Name:X-Suit NIR Biliary Metallic Stent
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant MEDINOL LTD. KIRYAT ATIDIM, BUILDING 8 Tel Aviv,  IL 6158101
ContactMichal Hershkovitz
CorrespondentH. Semih Oktay
CARDIOMED DEVICE CONSULTANTS, LLC 5523 RESEARCH PARK DRIVE SUITE 360 Baltimore,  MD  21228
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-25
Decision Date2016-02-12

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