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FDA 510(k)

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

K-Number: K202218 · 2020-10-02

ApplicantBoston Scientific Corporation
Decision Date2020-10-02
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-10-02 under approval number K202218. 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 ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device?

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Boston Scientific Corporation. The 510(k) number is K202218.

When was ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device approved by the FDA?

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device received FDA 510(k) clearance on 2020-10-02, under approval number K202218.

What company makes ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device?

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device is manufactured by Boston Scientific Corporation.

What is the FDA product code for ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device?

The FDA product code for ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device is QEW.

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Related PubMed Literature

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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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