FDA 510(k)

DUO Microcatheter

K-Number: K250960 · 2025-09-08

Decision Date2025-09-08

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

DUO Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Rev Neuro, LLC. It received FDA 510(k) clearance on 2025-09-08 under 510(k) number K250960. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUO Microcatheter?

DUO Microcatheter is a medical device that received FDA 510(k) clearance on 2025-09-08. The listed applicant is Rev Neuro, LLC. The 510(k) number is K250960.

When did DUO Microcatheter receive FDA 510(k) clearance?

DUO Microcatheter received FDA 510(k) clearance on 2025-09-08, under 510(k) number K250960.

Who is the listed applicant for DUO Microcatheter?

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

What is the FDA product code for DUO Microcatheter?

The FDA product code for DUO Microcatheter is QJP.

Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLC K253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker Neurovascular K261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo Neuro K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro K253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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.