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FDA 510(k)

Penumbra System (RED 68 Reperfusion Catheter)

K-Number: K211411 · 2021-07-01

ApplicantPenumbra, Inc.
Decision Date2021-07-01
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Penumbra System (RED 68 Reperfusion Catheter) is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2021-07-01 under approval number K211411. 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 (RED 68 Reperfusion Catheter)?

Penumbra System (RED 68 Reperfusion Catheter) is a medical device that received FDA 510(k) clearance on 2021-07-01. It is manufactured by Penumbra, Inc.. The 510(k) number is K211411.

When was Penumbra System (RED 68 Reperfusion Catheter) approved by the FDA?

Penumbra System (RED 68 Reperfusion Catheter) received FDA 510(k) clearance on 2021-07-01, under approval number K211411.

What company makes Penumbra System (RED 68 Reperfusion Catheter)?

Penumbra System (RED 68 Reperfusion Catheter) is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra System (RED 68 Reperfusion Catheter)?

The FDA product code for Penumbra System (RED 68 Reperfusion Catheter) 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.

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