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FDA 510(k)

Penumbra Coil 400, Ruby Coil System, POD System

K-Number: K173614 · 2018-04-17

ApplicantPenumbra, Inc.
Decision Date2018-04-17
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Penumbra Coil 400, Ruby Coil System, POD System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2018-04-17 under approval number K173614. 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 Coil 400, Ruby Coil System, POD System?

Penumbra Coil 400, Ruby Coil System, POD System is a medical device that received FDA 510(k) clearance on 2018-04-17. It is manufactured by Penumbra, Inc.. The 510(k) number is K173614.

When was Penumbra Coil 400, Ruby Coil System, POD System approved by the FDA?

Penumbra Coil 400, Ruby Coil System, POD System received FDA 510(k) clearance on 2018-04-17, under approval number K173614.

What company makes Penumbra Coil 400, Ruby Coil System, POD System?

Penumbra Coil 400, Ruby Coil System, POD System is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra Coil 400, Ruby Coil System, POD System?

The FDA product code for Penumbra Coil 400, Ruby Coil System, POD System is HCG.

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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