Boss Crossing Support Catheter

Catheter, Percutaneous

Marvao Medical Devices Ltd

The following data is part of a premarket notification filed by Marvao Medical Devices Ltd with the FDA for Boss Crossing Support Catheter.

Pre-market Notification Details

Device IDK220632
510k NumberK220632
Device Name:Boss Crossing Support Catheter
ClassificationCatheter, Percutaneous
Applicant Marvao Medical Devices Ltd Unit 1 Galway Business Park, Dangan Galway,  IE H91A3EF
ContactChris Davey
CorrespondentMary P. LeGraw
Avania Ltd 100 Crowley Drive, Suite 216 Marlborough,  MA  01752
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-04
Decision Date2022-06-02

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