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510(k) K200932

Blood Collection Needles by Vacutest Kima Srl — Product Code FMI

K200932 is an FDA 510(k) premarket notification submitted by Vacutest Kima Srl for the device "Blood Collection Needles". The FDA issued a decision of Substantially Equivalent on Dec 14, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 14, 2021
Date Received
Apr 7, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type
510(k)

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FDA data resources