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510(k) K222780

LILY Extension Tube and Needleless Connector by Lily Medical Corporation — Product Code FPA

K222780 is an FDA 510(k) premarket notification submitted by Lily Medical Corporation for the device "LILY Extension Tube and Needleless Connector". The FDA issued a decision of Substantially Equivalent on November 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
November 9, 2023
Date Received
September 14, 2022
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

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FDA data resources