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FDA 510(k)

ICE Aspiration System

K-Number: K234073 · 2024-04-19

ApplicantExpanse Medical, Inc.
Decision Date2024-04-19
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ICE Aspiration System is a medical device manufactured by Expanse Medical, Inc.. It received FDA 510(k) clearance on 2024-04-19 under approval number K234073. 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 ICE Aspiration System?

ICE Aspiration System is a medical device that received FDA 510(k) clearance on 2024-04-19. It is manufactured by Expanse Medical, Inc.. The 510(k) number is K234073.

When was ICE Aspiration System approved by the FDA?

ICE Aspiration System received FDA 510(k) clearance on 2024-04-19, under approval number K234073.

What company makes ICE Aspiration System?

ICE Aspiration System is manufactured by Expanse Medical, Inc..

What is the FDA product code for ICE Aspiration System?

The FDA product code for ICE 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 Expanse Medical, Inc.

K251488FLOWRUNNER Aspiration System K254208FLOWRUNNER Aspiration System

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO 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.

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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