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FDA 510(k)

WOLF Thrombectomy Device

K-Number: K182835 · 2019-03-27

Applicant880 Medical, LLC
Decision Date2019-03-27
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WOLF Thrombectomy Device is a medical device manufactured by 880 Medical, LLC. It received FDA 510(k) clearance on 2019-03-27 under approval number K182835. 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 WOLF Thrombectomy Device?

WOLF Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2019-03-27. It is manufactured by 880 Medical, LLC. The 510(k) number is K182835.

When was WOLF Thrombectomy Device approved by the FDA?

WOLF Thrombectomy Device received FDA 510(k) clearance on 2019-03-27, under approval number K182835.

What company makes WOLF Thrombectomy Device?

WOLF Thrombectomy Device is manufactured by 880 Medical, LLC.

What is the FDA product code for WOLF Thrombectomy Device?

The FDA product code for WOLF 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

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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