FDA 510(k) Application Details - K223791

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K223791
Device Name	Wire, Guide, Catheter
Applicant	Embrace Medical Ltd. 21(B) Habarzel Street Tel-Aviv 6971029 IL Other 510(k) Applications for this Company
Contact	Anat Kaufman Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/2022
Decision Date	07/14/2023
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