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FDA 510(k)

ClotTriever BOLD Catheter

K-Number: K230494 · 2023-04-18

ApplicantInari Medical, Inc.
Decision Date2023-04-18
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ClotTriever BOLD Catheter is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-04-18 under approval number K230494. 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 BOLD Catheter?

ClotTriever BOLD Catheter is a medical device that received FDA 510(k) clearance on 2023-04-18. It is manufactured by Inari Medical, Inc.. The 510(k) number is K230494.

When was ClotTriever BOLD Catheter approved by the FDA?

ClotTriever BOLD Catheter received FDA 510(k) clearance on 2023-04-18, under approval number K230494.

What company makes ClotTriever BOLD Catheter?

ClotTriever BOLD Catheter is manufactured by Inari Medical, Inc..

What is the FDA product code for ClotTriever BOLD Catheter?

The FDA product code for ClotTriever BOLD Catheter is QEW.

Other Devices by Inari Medical, Inc.

K163549ClotTriever Thrombectomy System K181325FlowTriever Retrieval/Aspiration System K180466FlowTriever Retrieval/Aspiration System K180329ClotTriever Thrombectomy System K203333Triever20 Curve Catheter K212632ClotTriever Thrombectomy 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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