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FDA 510(k)

Triever16 Curve

K-Number: K223419 · 2023-03-23

ApplicantInari Medical
Decision Date2023-03-23
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Triever16 Curve is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K223419. 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 Triever16 Curve?

Triever16 Curve is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Inari Medical. The 510(k) number is K223419.

When did Triever16 Curve receive FDA 510(k) clearance?

Triever16 Curve received FDA 510(k) clearance on 2023-03-23, under 510(k) number K223419.

Who is the listed applicant for Triever16 Curve?

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

What is the FDA product code for Triever16 Curve?

The FDA product code for Triever16 Curve 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.

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