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FDA 510(k)

LimFlow ARC

K-Number: K221541 · 2022-08-31

ApplicantLimFlow, Inc.
Decision Date2022-08-31
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LimFlow ARC is the device name listed in this FDA 510(k) record. The listed applicant is LimFlow, Inc.. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K221541. 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 2022-08-31. The listed applicant is LimFlow, Inc.. The 510(k) number is K221541.

When did LimFlow ARC receive FDA 510(k) clearance?

LimFlow ARC received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221541.

Who is the listed applicant for LimFlow ARC?

The FDA 510(k) record lists LimFlow, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LimFlow ARC?

The FDA product code for LimFlow ARC is PDU.

Other records listing LimFlow, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260188LimFlow VectorPMA P220025Stent graft, infrapopliteal, venous arterializationK251376LimFlow ARCK242776LimFlow V-CeiverK221902LimFlow VectorK222083LimFlow V-Ceiver

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Related Devices (Code: PDU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.

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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