FDA 510(k) Application Details - K240119

Device Classification Name	More FDA Info for this Device
510(K) Number	K240119
Device Name	VasQ
Applicant	Laminate Medical Technologies Ltd. 24 Raoul Wallenberg Tel Aviv 6971921 IL Other 510(k) Applications for this Company
Contact	Orit Yarden Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/16/2024
Decision Date	02/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review