Penumbra wins FDA nod for Ace64 thrombectomy device

Penumbra says it won 510(k) clearance from the FDA for its Ace64 intra-arterial stent.

Penumbra said today that it has received 510(k) clearance from the FDA for its Ace64 aspiration thrombectomy device, based on data from the Mr. Clean trial and additional randomized controlled stroke trials.

Food & Drug Administration (FDA), Penumbra Inc.

News Well, 510(k), Regulatory/Compliance, Stroke

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