FDA 510(k) Application Details - K234123

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K234123
Device Name	Device, Vascular, For Promoting Embolization
Applicant	ABK Biomedical Inc 155 Chain Lake Drive Unit 32 Halifax B3S 1B3 CA Other 510(k) Applications for this Company
Contact	Brandi Woods Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/28/2023
Decision Date	02/13/2024
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