Penumbra System (Reperfusion Catheter RED 72)
K-Number: K211654 · 2021-08-16
ApplicantPenumbra, Inc.
Decision Date2021-08-16
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Penumbra System (Reperfusion Catheter RED 72) is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2021-08-16 under approval number K211654. 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 (Reperfusion Catheter RED 72)?
Penumbra System (Reperfusion Catheter RED 72) is a medical device that received FDA 510(k) clearance on 2021-08-16. It is manufactured by Penumbra, Inc.. The 510(k) number is K211654.
When was Penumbra System (Reperfusion Catheter RED 72) approved by the FDA?
Penumbra System (Reperfusion Catheter RED 72) received FDA 510(k) clearance on 2021-08-16, under approval number K211654.
What company makes Penumbra System (Reperfusion Catheter RED 72)?
Penumbra System (Reperfusion Catheter RED 72) is manufactured by Penumbra, Inc..
What is the FDA product code for Penumbra System (Reperfusion Catheter RED 72)?
The FDA product code for Penumbra System (Reperfusion Catheter RED 72) is NRY.
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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.