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510(k) K244047

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) by Venocare, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2025
Date Received
December 31, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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