510(k) K230992

DJF Intravascular Administration Set by Yangzhou Wei DE LI Trade Co., Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2023
Date Received
April 6, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type