510(k) K230992

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

K230992 is an FDA 510(k) premarket notification submitted by Yangzhou Wei DE LI Trade Co., Ltd. for the device "DJF Intravascular Administration Set". The FDA issued a decision of Substantially Equivalent on June 9, 2023. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440.

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