FDA 510(k) Application Details - K233924

Device Classification Name	More FDA Info for this Device
510(K) Number	K233924
Device Name	EMBOGUARD Balloon Guide Catheter
Applicant	Neuravi Limited Block 3 Ballybrit Business Park Galway IE Other 510(k) Applications for this Company
Contact	Niall Fox 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	12/13/2023
Decision Date	04/18/2024
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