FDA 510(k) Application Details - K220962

Device Classification Name	Catheter, Peripheral, Atherectomy   More FDA Info for this Device
510(K) Number	K220962
Device Name	Catheter, Peripheral, Atherectomy
Applicant	Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	Heather Schuchard Other 510(k) Applications for this Contact
Regulation Number	870.4875   More FDA Info for this Regulation Number
Classification Product Code	MCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2022
Decision Date	09/06/2022
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