FDA 510(k) Application Details - K211893

Device Classification Name	More FDA Info for this Device
510(K) Number	K211893
Device Name	SelectFlex Neurovascular Access System Family
Applicant	Q'Apel Medical Inc 46708 Lakeview Boulevard Fremont, AR 94538 US Other 510(k) Applications for this Company
Contact	Ken Peartree Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2021
Decision Date	08/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review