FDA 510(k)

Penumbra Coil 400, Ruby Coil System, POD System

K-Number: K173614 · 2018-04-17

Decision Date2018-04-17

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Penumbra Coil 400, Ruby Coil System, POD System is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2018-04-17 under 510(k) 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. The listed applicant is Penumbra, Inc.. The 510(k) number is K173614.

When did Penumbra Coil 400, Ruby Coil System, POD System receive FDA 510(k) clearance?

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

Who is the listed applicant for Penumbra Coil 400, Ruby Coil System, POD System?

The FDA 510(k) record lists Penumbra, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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Other records listing Penumbra, Inc. as applicant

K250690Penumbra System (Thunderbolt Aspiration Tubing)K260599INDIGO® Aspiration System – INDIGO Link K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing K250079Ruby XL System K242104Penumbra System (Reperfusion Catheter RED 72)

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Related Devices (Code: HCG)

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.