FDA 510(k) Application Details - K223432

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K223432
Device Name	Wire, Guide, Catheter
Applicant	Filmecc CO., LTD 1703 Wakita-cho, Moriyama-ku Nagoya-shi 463-0024 JP Other 510(k) Applications for this Company
Contact	Toshiya Osawa Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2022
Decision Date	03/09/2023
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