FDA 510(k)

Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)

K-Number: K252277 · 2025-10-20

ApplicantVascular Flow Technologies Limited

Decision Date2025-10-20

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) is a medical device manufactured by Vascular Flow Technologies Limited. It received FDA 510(k) clearance on 2025-10-20 under approval number K252277. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)?

Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) is a medical device that received FDA 510(k) clearance on 2025-10-20. It is manufactured by Vascular Flow Technologies Limited. The 510(k) number is K252277.

When was Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) approved by the FDA?

Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) received FDA 510(k) clearance on 2025-10-20, under approval number K252277.

What company makes Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)?

Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) is manufactured by Vascular Flow Technologies Limited.

What is the FDA product code for Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)?

The FDA product code for Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) is DSY.

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Related PubMed Literature

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.