FDA 510(k)

Excipio SV Thrombectomy Device

K-Number: K221204 · 2022-06-23

Decision Date2022-06-23

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Excipio SV Thrombectomy Device is a medical device manufactured by Contego Medical, Inc.. It received FDA 510(k) clearance on 2022-06-23 under approval number K221204. 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 SV Thrombectomy Device?

Excipio SV Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2022-06-23. It is manufactured by Contego Medical, Inc.. The 510(k) number is K221204.

When was Excipio SV Thrombectomy Device approved by the FDA?

Excipio SV Thrombectomy Device received FDA 510(k) clearance on 2022-06-23, under approval number K221204.

What company makes Excipio SV Thrombectomy Device?

Excipio SV Thrombectomy Device is manufactured by Contego Medical, Inc..

What is the FDA product code for Excipio SV Thrombectomy Device?

The FDA product code for Excipio SV 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 NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING NCT03359434 Blood Pressure Measurement Methods and Prediction of Intracranial Hemorrhage After Thrombectomy in Stroke COMPLETED NCT06733246 Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients RECRUITING

Other Devices by Contego Medical, Inc.

K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection K230030Excipio SV Aspiration Catheter and Tubing K223897Excipio LV Thrombectomy Device K251485Excipio LV Prime 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

View on FDA Database →

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