510(k) K181870

Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use by Wuhan W.E.O Science & Technology Development Co., Ltd. — Product Code FPA

K181870 is an FDA 510(k) premarket notification submitted by Wuhan W.E.O Science & Technology Development Co., Ltd. for the device "Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use". The FDA issued a decision of Substantially Equivalent on Feb 26, 2019. 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
Feb 26, 2019
Date Received
Jul 12, 2018
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
510(k)