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FDA 510(k)

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

K-Number: K160533 · 2016-05-24

ApplicantPenumbra, Inc.
Decision Date2016-05-24
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2016-05-24 under approval number K160533. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)?

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is a medical device that received FDA 510(k) clearance on 2016-05-24. It is manufactured by Penumbra, Inc.. The 510(k) number is K160533.

When was Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) approved by the FDA?

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) received FDA 510(k) clearance on 2016-05-24, under approval number K160533.

What company makes Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)?

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is manufactured by Penumbra, Inc..

What is the FDA product code for Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)?

The FDA product code for Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) is QEW.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT06571760 Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I COMPLETED NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING

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 K160832Penumbra Smart Coil

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Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari Medical, Inc. K182167The ICHOR Panacea Vascular Embolectomy Catheter SystemIchor Vascular, Inc.

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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