FDA 510(k) Application Details - K243383

Device Classification Name	Guide, Wire, Catheter, Neurovasculature   More FDA Info for this Device
510(K) Number	K243383
Device Name	Guide, Wire, Catheter, Neurovasculature
Applicant	ASAHI INTECC CO., LTD. 3-100 Akatsuki-cho Seto 489-0071 JP Other 510(k) Applications for this Company
Contact	Katsuhiko Fujimura Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	MOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2024
Decision Date	04/21/2025
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	N
Expedited Review