Source document or public record
FDA 510(k) K244047 — Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
FDA 510(k) index record K244047. Device: Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG). Applicant as listed: Venocare, Inc.. Decision date: 2025-05-23.
Source
"device_name": "Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K244047.
Device name: Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG). Applicant as listed: Venocare, Inc..
Decision date: 2025-05-23. Decision wording: Substantially Equivalent.
Product code: JKA. Regulation: 21 CFR 862.1675. Medical specialty: Clinical Chemistry.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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