FDA 510(k) Application Details - K242254

Device Classification Name	More FDA Info for this Device
510(K) Number	K242254
Device Name	D╖KuttingÖ LL Peripheral Scoring Balloon Dilatation Catheter
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	Quan Shi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2024
Decision Date	04/21/2025
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