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FDA 510(k)

Penumbra System Penumbra JET 7X

K-Number: K191946 · 2020-02-27

ApplicantPenumbra, Inc.
Decision Date2020-02-27
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Penumbra System Penumbra JET 7X is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2020-02-27 under approval number K191946. 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 Penumbra JET 7X?

Penumbra System Penumbra JET 7X is a medical device that received FDA 510(k) clearance on 2020-02-27. It is manufactured by Penumbra, Inc.. The 510(k) number is K191946.

When was Penumbra System Penumbra JET 7X approved by the FDA?

Penumbra System Penumbra JET 7X received FDA 510(k) clearance on 2020-02-27, under approval number K191946.

What company makes Penumbra System Penumbra JET 7X?

Penumbra System Penumbra JET 7X is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra System Penumbra JET 7X?

The FDA product code for Penumbra System Penumbra JET 7X is NRY.

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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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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