FDA 510(k) Application Details - K240387

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K240387
Device Name	Wire, Guide, Catheter
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	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2024
Decision Date	06/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review