FDA 510(k) Application Details - K223275

Device Classification Name	More FDA Info for this Device
510(K) Number	K223275
Device Name	CELLO II Balloon Guide Catheter
Applicant	Fuji Systems Corporation 200-2, Aza-Ohira, Odakura, Nishigo Nishi Shirakawa Gun 961-8061 JP Other 510(k) Applications for this Company
Contact	Yoshiyuki Suzuki 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	10/24/2022
Decision Date	12/09/2022
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	Y
Expedited Review