FDA 510(k) Application Details - K232536

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K232536
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Embolx, Inc. 530 Lakeside Dr. Suite 200 Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Louise Musante Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2023
Decision Date	02/23/2024
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