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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K261089

510(k) cleared

Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit

Maduro Medical, Inc. · Sep 14, 2026 · K261089

FDA cleared the Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit from Maduro Medical, Inc. on Sep 14, 2026 under K261089, a traditional 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 1, 2026. The decision came 166 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Maduro Medical, Inc. has one other decision in the tracker over the last 12 months: K253975 (Radical 6F Access Catheter).

Questions & Answers

What did FDA clear under K261089?

K261089 is the FDA 510(k) for Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit, submitted by Maduro Medical, Inc.. FDA's decision date was Sep 14, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit?

Maduro Medical, Inc., based in Los Gatos, CA, is the applicant of record for K261089.

How long did the K261089 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Sep 14, 2026, 166 days later.

← All decisions in September 2026

Sources