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510(k) K222766

Disposable Extension Set by Shandong Ande Healthcare Apparatus Co., Ltd. — Product Code FPA

K222766 is an FDA 510(k) premarket notification submitted by Shandong Ande Healthcare Apparatus Co., Ltd. for the device "Disposable Extension Set". The FDA issued a decision of Substantially Equivalent on April 12, 2024. 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
April 12, 2024
Date Received
September 13, 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