FDA 510(k) Application Details - K200648

Device Classification Name	More FDA Info for this Device
510(K) Number	K200648
Device Name	EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
Applicant	EKOS Corporation 11911 North Creek Parkway S Bothell, WA 98011 US Other 510(k) Applications for this Company
Contact	Joshua Kim Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2020
Decision Date	08/17/2020
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