FDA 510(k) Application Details - K243944

Device Classification Name	More FDA Info for this Device
510(K) Number	K243944
Device Name	Aperta NSE PTA Balloon Dilatation Catheter
Applicant	Goodman Co., Ltd. 5F KDX Nagoya Sakae Building 4-5-3 Sakae, Naka-ku, Nagoya Nagoya 460-0008 JP Other 510(k) Applications for this Company
Contact	Kanechika Aida 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	12/20/2024
Decision Date	04/22/2025
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