FDA 510(k) Application Details - K242676

Device Classification Name	More FDA Info for this Device
510(K) Number	K242676
Device Name	pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
Applicant	phenox Limited Kamrick Court Ballybrit Business Park Galway H91XY38 IE Other 510(k) Applications for this Company
Contact	Rachel McDaid 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	09/06/2024
Decision Date	02/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review