Bridge Occlusion Balloon

Catheter, Intravascular Occluding, Temporary

Spectranetics, Inc.

The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Bridge Occlusion Balloon.

Pre-market Notification Details

Device IDK203540
510k NumberK203540
Device Name:Bridge Occlusion Balloon
ClassificationCatheter, Intravascular Occluding, Temporary
Applicant Spectranetics, Inc. 9965 Federal Drive Colorado Springs,  CO  80921
ContactSondra Chandler
CorrespondentSondra Chandler
Spectranetics, Inc. 9965 Federal Drive Colorado Springs,  CO  80921
Product CodeMJN  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-03
Decision Date2020-12-23

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