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SoundBite® Crossing System XS Peripheral — Soundbite Medical Solutions, Inc. (510(k) K230159)

SoundBite® Crossing System XS Peripheral — Soundbite Medical Solutions, Inc. (510(k) K230159) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: SoundBite® Crossing System XS Peripheral; Applicant: Soundbite Medical Solutions, Inc.; Clearance track: 510(k).

Device nameSoundBite® Crossing System XS Peripheral
ApplicantSoundbite Medical Solutions, Inc.
Clearance track510(k)
Submission numberK230159
DecisionSubstantially Equivalent
Decision date2023-08-28
Date received2023-01-19
Product codePDU
Device class2
Medical specialtyCardiovascular
Applicant locationCA
SourceopenFDA device

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