OLYMPUS B-5/B-7 SERIESBALLOON CATHETER

Stents, Drains And Dilators For The Biliary Ducts

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus B-5/b-7 Seriesballoon Catheter.

Pre-market Notification Details

Device IDK962925
510k NumberK962925
Device Name:OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-29
Decision Date1996-10-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170047487 K962925 000
14953170047449 K962925 000
14953170047371 K962925 000
14953170463751 K962925 000
14953170463706 K962925 000
14953170463683 K962925 000

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