FDA 510(k) Application Details - K220866

Device Classification Name	More FDA Info for this Device
510(K) Number	K220866
Device Name	EKOS+ Endovascular Device
Applicant	Boston Scientific Two Scimed Place Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	Daniel Root 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	03/25/2022
Decision Date	04/20/2022
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