FDA 510(k) Application Details - K214009

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K214009
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	DK Medical Technology Co., Ltd. 301 unit, bioBAY B1, 218 Xinghu Str., Suzhou Industrial Park Suzhou 215123 CN Other 510(k) Applications for this Company
Contact	Shi Quan Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	LIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2021
Decision Date	04/05/2023
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