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The Tracker / September 2026 / K253419

510(k) cleared

Triever Duo Catheter

Inari Medical, Inc. · Sep 18, 2026 · K253419

FDA cleared the Triever Duo Catheter from Inari Medical, Inc. on Sep 18, 2026 under K253419, a traditional 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Oct 1, 2025. The decision came 352 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Inari Medical, Inc. has 3 other decisions in the tracker over the last 12 months: K262538 (Artix MT;Artix Thin-Walled Sheath), K252508 (Intri26 Introducer Sheath), K253323 (Protrieve Sheath).

Questions & Answers

What did FDA clear under K253419?

K253419 is the FDA 510(k) for Triever Duo Catheter, submitted by Inari Medical, Inc.. FDA's decision date was Sep 18, 2026, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Triever Duo Catheter?

Inari Medical, Inc., based in Irvine, CA, is the applicant of record for K253419.

How long did the K253419 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Sep 18, 2026, 352 days later.

← All decisions in September 2026

Sources