FDA 510(k) Application Details - K222848

Device Classification Name	More FDA Info for this Device
510(K) Number	K222848
Device Name	pRESET Thrombectomy Device
Applicant	phenox Limited Kamrick Court, Ballybrit Business Park, Galway H91XY38 IE Other 510(k) Applications for this Company
Contact	Catriona Lynch Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2022
Decision Date	01/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review