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IState)51()Nme Name of Manufacturer (Town, - Food and Drug

IState)51()Nme Name of Manufacturer (Town, - Food and Drug 2025

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The document is a 510(k) summary for the Penumbra Embolectomy Aspiration System, submitted by Penumbra Inc. It outlines the device's intended use for removing fresh, soft emboli and thrombi from peripheral arterial vessels, its classification as a Class II embolectomy catheter, and its substantial equivalence to predicate devices. The summary includes details on the device's description, non-clinical data supporting safety and effectiveness, biocompatibility testing results, and compliance with regulatory requirements.

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