FDA 510(k) Application Details - K232013

Device Classification Name	More FDA Info for this Device
510(K) Number	K232013
Device Name	Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14
Applicant	Goodman Co., Ltd. 5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-ku Nagoya 460-0008 JP Other 510(k) Applications for this Company
Contact	Aida Kanechika Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2023
Decision Date	03/28/2024
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