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FDA 510(k)

Penumbra System, Penumbra Pump MAX

K-Number: K160449 · 2016-05-25

ApplicantPenumbra, Inc.
Decision Date2016-05-25
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Penumbra System, Penumbra Pump MAX is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2016-05-25 under approval number K160449. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Penumbra System, Penumbra Pump MAX?

Penumbra System, Penumbra Pump MAX is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Penumbra, Inc.. The 510(k) number is K160449.

When was Penumbra System, Penumbra Pump MAX approved by the FDA?

Penumbra System, Penumbra Pump MAX received FDA 510(k) clearance on 2016-05-25, under approval number K160449.

What company makes Penumbra System, Penumbra Pump MAX?

Penumbra System, Penumbra Pump MAX is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra System, Penumbra Pump MAX?

The FDA product code for Penumbra System, Penumbra Pump MAX is NRY.

Related Clinical Trials

NCT07107022 Study to Collect Real-world Performance and Safety Data on Penumbra System® in Population With Acute Ischemic Stroke (AIS). RECRUITING

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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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