FDA 510(k) Application Details - K230709

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K230709
Device Name	Catheter, Peripheral, Atherectomy
Applicant	Eximo Medical Ltd. Pekeris St 3 Rehovot 7670203 IL Other 510(k) Applications for this Company
Contact	Yoel Zabar Other 510(k) Applications for this Contact
Regulation Number	870.4875   More FDA Info for this Regulation Number
Classification Product Code	MCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2023
Decision Date	06/09/2023
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