FDA 510(k)

Excipio LV Prime Thrombectomy Device

K-Number: K251485 · 2025-06-13

Decision Date2025-06-13

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Excipio LV Prime Thrombectomy Device is a medical device manufactured by Contego Medical, Inc.. It received FDA 510(k) clearance on 2025-06-13 under approval number K251485. 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 Excipio LV Prime Thrombectomy Device?

Excipio LV Prime Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2025-06-13. It is manufactured by Contego Medical, Inc.. The 510(k) number is K251485.

When was Excipio LV Prime Thrombectomy Device approved by the FDA?

Excipio LV Prime Thrombectomy Device received FDA 510(k) clearance on 2025-06-13, under approval number K251485.

What company makes Excipio LV Prime Thrombectomy Device?

Excipio LV Prime Thrombectomy Device is manufactured by Contego Medical, Inc..

What is the FDA product code for Excipio LV Prime Thrombectomy Device?

The FDA product code for Excipio LV Prime Thrombectomy Device is QEW.

Related Clinical Trials

NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07356284 Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis RECRUITING NCT07566598 Measuring Absolute Brain Flow and Brain Microcirculation Resistance by Continuous Thermodilution RECRUITING NCT03735667 ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement ACTIVE_NOT_RECRUITING NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING NCT03507205 Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents COMPLETED

Other Devices by Contego Medical, Inc.

K221204Excipio SV Thrombectomy Device K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection K230030Excipio SV Aspiration Catheter and Tubing K223897Excipio LV Thrombectomy Device PMA P240009Stent, carotid

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.