FDA 510(k) Application Details - K233948

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K233948
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Provisio Medical, Inc. 10815 Rancho Bernardo Road Suite 110 San Diego, CA 92127 US Other 510(k) Applications for this Company
Contact	Robert Ashley Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2023
Decision Date	04/23/2024
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