FDA 510(k) Application Details - K200812

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K200812
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Philips Image Guided Therapy Corporation 3721 Valley Centre Drive., Suite 500 San Diego, CA 92130 US Other 510(k) Applications for this Company
Contact	Rand Daoud 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	03/27/2020
Decision Date	09/02/2020
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