Penumbra LP Coil System
K-Number: K230284 · 2023-10-25
ApplicantPenumbra, Inc.
Decision Date2023-10-25
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Penumbra LP Coil System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2023-10-25 under approval number K230284. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Penumbra LP Coil System?
Penumbra LP Coil System is a medical device that received FDA 510(k) clearance on 2023-10-25. It is manufactured by Penumbra, Inc.. The 510(k) number is K230284.
When was Penumbra LP Coil System approved by the FDA?
Penumbra LP Coil System received FDA 510(k) clearance on 2023-10-25, under approval number K230284.
What company makes Penumbra LP Coil System?
Penumbra LP Coil System is manufactured by Penumbra, Inc..
What is the FDA product code for Penumbra LP Coil System?
The FDA product code for Penumbra LP Coil System is HCG.
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.