FDA 510(k) Application Details - K221279

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K221279
Device Name	Catheter, Intravascular, Diagnostic
Applicant	phenox Ltd Kamrick Court, Ballybrit Business Park Galway H91 XY38 IE Other 510(k) Applications for this Company
Contact	Sarah Cregg Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/2022
Decision Date	11/28/2022
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	Y
Expedited Review