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FDA 510(k)

Triever Duo Catheter

K-Number: K253419 · 2026-09-18

ApplicantInari Medical, Inc.
Decision Date2026-09-18
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Triever Duo Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical, Inc.. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K253419. 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 Triever Duo Catheter?

Triever Duo Catheter is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Inari Medical, Inc.. The 510(k) number is K253419.

When did Triever Duo Catheter receive FDA 510(k) clearance?

Triever Duo Catheter received FDA 510(k) clearance on 2026-09-18, under 510(k) number K253419.

Who is the listed applicant for Triever Duo Catheter?

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

What is the FDA product code for Triever Duo Catheter?

The FDA product code for Triever Duo Catheter is QEW.

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Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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