FDA 510(k) Application Details - K233420

Device Classification Name	Device, Neurovascular Embolization   More FDA Info for this Device
510(K) Number	K233420
Device Name	Device, Neurovascular Embolization
Applicant	Micro Therapeutics, lnc. d/b/a ev3 Neurovascular 9775 Toledo Way lrvine, CA 92612 US Other 510(k) Applications for this Company
Contact	Lekshmi Ajaykumar Pillai Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	HCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/10/2023
Decision Date	11/07/2023
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