SoundBite Console, SoundBite Active Wire 18

Catheter For Crossing Total Occlusions

SoundBite Medical Solution Inc.

The following data is part of a premarket notification filed by Soundbite Medical Solution Inc. with the FDA for Soundbite Console, Soundbite Active Wire 18.

Pre-market Notification Details

Device IDK192211
510k NumberK192211
Device Name:SoundBite Console, SoundBite Active Wire 18
ClassificationCatheter For Crossing Total Occlusions
Applicant SoundBite Medical Solution Inc. 2300 Blvd Alfred Nobel Montreal,  CA H4s 2a4
ContactMarc Andre Cote
CorrespondentMarc Andre Cote
SoundBite Medical Solution Inc. 2300 Blvd Alfred Nobel Montreal,  CA H4s 2a4
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-14
Decision Date2020-01-17

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