FDA 510(k) Application Details - K231218

Device Classification Name	More FDA Info for this Device
510(K) Number	K231218
Device Name	Distal Access Catheter
Applicant	AccuMedical Beijing Ltd. 101, 1st Floor, Building 3, Maohua Factory, No.1, Caida 3rd Street, Nancai Town, Shunyi District Beijing 101300 CN Other 510(k) Applications for this Company
Contact	Dawei Long 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	04/28/2023
Decision Date	01/19/2024
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	N
Expedited Review