FDA 510(k)

Penumbra System 3D Revascularization Device

K-Number: K190464 · 2019-04-26

Decision Date2019-04-26

Product CodeNRY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Penumbra System 3D Revascularization Device is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2019-04-26 under approval number K190464. 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 3D Revascularization Device?

Penumbra System 3D Revascularization Device is a medical device that received FDA 510(k) clearance on 2019-04-26. It is manufactured by Penumbra, Inc.. The 510(k) number is K190464.

When was Penumbra System 3D Revascularization Device approved by the FDA?

Penumbra System 3D Revascularization Device received FDA 510(k) clearance on 2019-04-26, under approval number K190464.

What company makes Penumbra System 3D Revascularization Device?

Penumbra System 3D Revascularization Device is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra System 3D Revascularization Device?

The FDA product code for Penumbra System 3D Revascularization Device is NRY.

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Other Devices by Penumbra, Inc.

K161506Penumbra Aspiration System K161640Penumbra System ACE 68 Reperfusion Catheter K161523INDIGO Aspiration System K161064Penumbra System ACE 68 Reperfusion Catheter K160449Penumbra System, Penumbra Pump MAX K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

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Related Devices (Code: NRY)

K161879Solitaire Platinum Revascularization DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K161064Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. K152541Penumbra System ACE 64 and ACE 68 Reperfusion CathetersPenumbra, Inc. K172448Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular

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.