FDA 510(k) Application Details - K212959

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K212959
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Siemens Medical Solutions USA, Inc. 22010 S.E. 51st Street Issaquah, WA 98029 US Other 510(k) Applications for this Company
Contact	HyunJung Lee 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	09/16/2021
Decision Date	10/15/2021
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