FDA 510(k) Application Details - K233917

Device Classification Name	More FDA Info for this Device
510(K) Number	K233917
Device Name	ICHOR 7F Embolectomy System (ICH-7F)
Applicant	ICHOR 1900 NW 25th St. Boca Raton, FL 33431 US Other 510(k) Applications for this Company
Contact	Timothy Blair Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2023
Decision Date	07/18/2024
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