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FDA 510(k)

LimFlow ARC

K-Number: K251376 · 2025-05-31

ApplicantLimFlow, Inc.
Decision Date2025-05-31
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LimFlow ARC is a medical device manufactured by LimFlow, Inc.. It received FDA 510(k) clearance on 2025-05-31 under approval number K251376. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LimFlow ARC?

LimFlow ARC is a medical device that received FDA 510(k) clearance on 2025-05-31. It is manufactured by LimFlow, Inc.. The 510(k) number is K251376.

When was LimFlow ARC approved by the FDA?

LimFlow ARC received FDA 510(k) clearance on 2025-05-31, under approval number K251376.

What company makes LimFlow ARC?

LimFlow ARC is manufactured by LimFlow, Inc..

What is the FDA product code for LimFlow ARC?

The FDA product code for LimFlow ARC is PDU.

Other Devices by LimFlow, Inc.

K221902LimFlow Vector K221541LimFlow ARC K222083LimFlow V-Ceiver K242776LimFlow V-Ceiver K260188LimFlow Vector PMA P220025Stent graft, infrapopliteal, venous arterialization

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Official Source

View on FDA Database →

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

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