FDA 510(k) Application Details - K221930

Device Classification Name	More FDA Info for this Device
510(K) Number	K221930
Device Name	CEREGLIDE 71 Intermediate Catheter
Applicant	Cerenovus, Inc. 6303 Blue Lagoon Drive, Suite 215 & 315 Miami, FL 33126 US Other 510(k) Applications for this Company
Contact	Ariell Joner 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	07/01/2022
Decision Date	03/09/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review