FDA 510(k) Application Details - K251560

Device Classification Name	More FDA Info for this Device
510(K) Number	K251560
Device Name	FUBUKI XF-R Neurovascular Long Sheath
Applicant	Asahi Intecc Co., Ltd. 3-100 Akatsuki-cho Seto 489-0071 JP Other 510(k) Applications for this Company
Contact	Fujimura Katsuhiko 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	05/21/2025
Decision Date	06/20/2025
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