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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K262538

510(k) cleared

Artix MT;Artix Thin-Walled Sheath

Inari Medical, Inc. · Aug 21, 2026 · K262538

FDA cleared the Artix MT;Artix Thin-Walled Sheath from Inari Medical, Inc. on Aug 21, 2026 under K262538, a special 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 Jul 23, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Inari Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K252508 (Intri26 Introducer Sheath), K253323 (Protrieve Sheath).

Questions & Answers

What did FDA clear under K262538?

K262538 is the FDA 510(k) for Artix MT;Artix Thin-Walled Sheath, submitted by Inari Medical, Inc.. FDA's decision date was Aug 21, 2026, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Artix MT;Artix Thin-Walled Sheath?

Inari Medical, Inc., based in Irvine, CA, is the applicant of record for K262538.

How long did the K262538 review take?

FDA received the submission on Jul 23, 2026 and issued its decision on Aug 21, 2026, 29 days later.

← All decisions in August 2026

Sources