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FDA 510(k)

Prodigy Thrombectomy System

K-Number: K214114 · 2022-04-06

ApplicantTruvic Medical, Inc.
Decision Date2022-04-06
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Prodigy Thrombectomy System is a medical device manufactured by Truvic Medical, Inc.. It received FDA 510(k) clearance on 2022-04-06 under approval number K214114. 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 Prodigy Thrombectomy System?

Prodigy Thrombectomy System is a medical device that received FDA 510(k) clearance on 2022-04-06. It is manufactured by Truvic Medical, Inc.. The 510(k) number is K214114.

When was Prodigy Thrombectomy System approved by the FDA?

Prodigy Thrombectomy System received FDA 510(k) clearance on 2022-04-06, under approval number K214114.

What company makes Prodigy Thrombectomy System?

Prodigy Thrombectomy System is manufactured by Truvic Medical, Inc..

What is the FDA product code for Prodigy Thrombectomy System?

The FDA product code for Prodigy Thrombectomy 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 NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING NCT07335341 Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System RECRUITING

Other Devices by Truvic Medical, Inc.

K223216Symphony Thrombectomy 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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