FDA 510(k) Application Details - K220881

Device Classification Name	More FDA Info for this Device
510(K) Number	K220881
Device Name	INOUE BALLOON A
Applicant	Toray Industries, Inc. 1-1, Nihombashi-Muromachi 2-Chome Chuo-ku 103-8666 JP Other 510(k) Applications for this Company
Contact	Satoshi Kakuyama Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2022
Decision Date	12/18/2022
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