FDA 510(k) Application Details - K213315

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K213315
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	Tomoya Eguchi 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	10/04/2021
Decision Date	07/01/2022
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