FDA 510(k) Application Details - K203723

Device Classification Name	More FDA Info for this Device
510(K) Number	K203723
Device Name	Branchor Balloon Guide Catheter
Applicant	Asahi Intecc Co., Ltd 3-100 Akatsuki-cho Seto 489-0071 JP Other 510(k) Applications for this Company
Contact	Yasuyuki Kawahara 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	12/21/2020
Decision Date	12/10/2021
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