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FDA 510(k) Application Details - K230159
Device Classification Name
More FDA Info for this Device
510(K) Number
K230159
Device Name
SoundBite« Crossing System XS Peripheral
Applicant
Soundbite Medical Solutions, Inc.
2300 Alfred Nobel, Suite 230
Montreal H4S 2A4 CA
Other 510(k) Applications for this Company
Contact
Diane Marceau
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PDU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/19/2023
Decision Date
08/28/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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