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FDA 510(k)

INDIGO Aspiration System

K-Number: K161523 · 2016-07-01

ApplicantPenumbra, Inc.
Decision Date2016-07-01
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INDIGO Aspiration System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2016-07-01 under approval number K161523. 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 INDIGO Aspiration System?

INDIGO Aspiration System is a medical device that received FDA 510(k) clearance on 2016-07-01. It is manufactured by Penumbra, Inc.. The 510(k) number is K161523.

When was INDIGO Aspiration System approved by the FDA?

INDIGO Aspiration System received FDA 510(k) clearance on 2016-07-01, under approval number K161523.

What company makes INDIGO Aspiration System?

INDIGO Aspiration System is manufactured by Penumbra, Inc..

What is the FDA product code for INDIGO Aspiration System?

The FDA product code for INDIGO 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 NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Other Devices by Penumbra, Inc.

K161506Penumbra Aspiration System K161640Penumbra System ACE 68 Reperfusion Catheter K161064Penumbra System ACE 68 Reperfusion Catheter K160449Penumbra System, Penumbra Pump MAX K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) K160832Penumbra Smart Coil

View all 59 devices →

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, 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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