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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K261800

510(k) cleared

Helo Max Thrombectomy System (HEL2090)

Endovascular Engineering · Sep 3, 2026 · K261800 · In the directory

FDA cleared the Helo Max Thrombectomy System (HEL2090) from Endovascular Engineering on Sep 3, 2026 under K261800, 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 Jun 1, 2026. The decision came 94 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Endovascular Engineering has one other decision in the tracker over the last 12 months: K252956 (Helo Thrombectomy System).

Questions & Answers

What did FDA clear under K261800?

K261800 is the FDA 510(k) for Helo Max Thrombectomy System (HEL2090), submitted by Endovascular Engineering. FDA's decision date was Sep 3, 2026, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Helo Max Thrombectomy System (HEL2090)?

Endovascular Engineering, based in Menlo Park, CA, is the applicant of record for K261800. The company is listed in the MedDevice Startups directory.

How long did the K261800 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Sep 3, 2026, 94 days later.

← All decisions in September 2026

Sources

In the startup directory

E2 (Endovascular Engineering)

Cardiovascular · Menlo Park, CA