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FDA 510(k)

ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath

K-Number: K173470 · 2017-12-04

ApplicantInari Medical
Decision Date2017-12-04
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2017-12-04 under approval number K173470. 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 Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath?

ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath is a medical device that received FDA 510(k) clearance on 2017-12-04. It is manufactured by Inari Medical. The 510(k) number is K173470.

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

ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath received FDA 510(k) clearance on 2017-12-04, under approval number K173470.

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

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

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

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

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT06394739 RevCore for In Stent 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

Other Devices by Inari Medical

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator K183198FlowTriever Retrieval/Aspiration System K182233FlowTriever Retrieval/Aspiration System K182531ClotTriever Thrombectomy System K181694FlowTriever Retrieval/Aspiration System K173672FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter

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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. K163549ClotTriever Thrombectomy SystemInari Medical, Inc. K182167The ICHOR Panacea Vascular Embolectomy Catheter SystemIchor Vascular, 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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