Single Use Biliary Balloon Dilator

Stents, Drains And Dilators For The Biliary Ducts

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Biliary Balloon Dilator.

Pre-market Notification Details

Device IDK143303
510k NumberK143303
Device Name:Single Use Biliary Balloon Dilator
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji,  JP 192-8507
ContactSheri Musgnung
CorrespondentSheri L Musgnung
OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-18
Decision Date2015-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170400022 K143303 000
14953170372275 K143303 000
14953170372299 K143303 000
14953170372312 K143303 000
14953170372336 K143303 000
14953170399982 K143303 000
14953170399999 K143303 000
14953170400008 K143303 000
14953170400015 K143303 000
14953170372251 K143303 000

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