Source document or public record
FDA 510(k) K220258 — 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
FDA 510(k) index record K220258. Device: 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000). Applicant as listed: Avia Vascular. Decision date: 2022-07-14.
Source
"device_name": "20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K220258.
Device name: 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000). Applicant as listed: Avia Vascular.
Decision date: 2022-07-14. 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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