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FDA 510(k)

Access25™ Delivery Microcatheter

K-Number: K242033 · 2024-12-11

Decision Date2024-12-11
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Access25™ Delivery Microcatheter is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2024-12-11 under approval number K242033. 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 Access25™ Delivery Microcatheter?

Access25™ Delivery Microcatheter is a medical device that received FDA 510(k) clearance on 2024-12-11. It is manufactured by Penumbra, Inc.. The 510(k) number is K242033.

When was Access25™ Delivery Microcatheter approved by the FDA?

Access25™ Delivery Microcatheter received FDA 510(k) clearance on 2024-12-11, under approval number K242033.

What company makes Access25™ Delivery Microcatheter?

Access25™ Delivery Microcatheter is manufactured by Penumbra, Inc..

What is the FDA product code for Access25™ Delivery Microcatheter?

The FDA product code for Access25™ Delivery Microcatheter is QJP.

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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.