FDA 510(k) Application Details - K212615

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K212615
Device Name	Wire, Guide, Catheter
Applicant	Flat Medical Co., Ltd. 9F.-1 No. 27, Sec. 1, Chang'an E. Rd. Zhongshan Dist. Taipei City 10441 TW Other 510(k) Applications for this Company
Contact	Tseng Shao Wei 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	08/18/2021
Decision Date	09/21/2022
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