FDA 510(k) Application Details - K212340

Device Classification Name	More FDA Info for this Device
510(K) Number	K212340
Device Name	EMBOGUARD Balloon Guide Catheter
Applicant	Neuravi Limited Block 3, Ballybrit Business Park Galway H91 K5YD 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	07/28/2021
Decision Date	12/17/2021
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