FDA 510(k) Application Details - DEN240017

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN240017
Device Name	ShortCut
Applicant	Pi-Cardia Ltd. 5 David Fikes St. Rehovot 7632805 IL Other 510(k) Applications for this Company
Contact	Hadas Givon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2024
Decision Date	09/27/2024
Decision	DENG -
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review