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FDA 510(k)

ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath

K-Number: K192332 · 2019-09-20

ApplicantInari Medical
Decision Date2019-09-20
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2019-09-20 under approval number K192332. 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 ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath?

ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath is a medical device that received FDA 510(k) clearance on 2019-09-20. It is manufactured by Inari Medical. The 510(k) number is K192332.

When was ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath approved by the FDA?

ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath received FDA 510(k) clearance on 2019-09-20, under approval number K192332.

What company makes ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath?

ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath is manufactured by Inari Medical.

What is the FDA product code for ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath?

The FDA product code for ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath is QEW.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System 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

Other Devices by Inari Medical

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath K183198FlowTriever Retrieval/Aspiration System K182233FlowTriever Retrieval/Aspiration System K182531ClotTriever Thrombectomy System K181694FlowTriever Retrieval/Aspiration System

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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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