FDA 510(k) Application Details - K241388

Device Classification Name	More FDA Info for this Device
510(K) Number	K241388
Device Name	Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
Applicant	Micro Therapeutics Inc. d/b/a ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Vesselina Clayton 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	05/15/2024
Decision Date	01/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review