FDA 510(k) Application Details - DEN230069

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230069
Device Name	Mi-CHORD System
Applicant	LSI SOLUTIONS, Inc. 7796 Victor-Mendon Road Victor, NY 14564 US Other 510(k) Applications for this Company
Contact	Christopher B. Miller Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	06/11/2024
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