FDA 510(k)

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device

K-Number: K202218 · 2020-10-02

Decision Date2020-10-02

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2020-10-02 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K202218.

When did ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device receive FDA 510(k) clearance?

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

Who is the listed applicant for ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: QEW)

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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.