Penumbra System
K-Number: K180008 · 2018-06-20
ApplicantPenumbra, Inc.
Decision Date2018-06-20
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Penumbra System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2018-06-20 under approval number K180008. 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 System is a medical device that received FDA 510(k) clearance on 2018-06-20. It is manufactured by Penumbra, Inc.. The 510(k) number is K180008.
When was Penumbra System approved by the FDA?
Penumbra System received FDA 510(k) clearance on 2018-06-20, under approval number K180008.
What company makes Penumbra System?
Penumbra System is manufactured by Penumbra, Inc..
What is the FDA product code for Penumbra System?
The FDA product code for Penumbra System is NRY.
Related Clinical Trials
Other Devices by Penumbra, Inc.
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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.