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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K260771

510(k) cleared

TruSelect 2.6 Microcatheter

Boston Scientific Corporation · May 15, 2026 · K260771

FDA cleared the TruSelect 2.6 Microcatheter from Boston Scientific Corporation on May 15, 2026 under K260771, a special 510(k). The device falls under product code KRA, Catheter, Continuous Flush, regulated at 21 CFR 870.1210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 9, 2026. The decision came 67 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform).

Questions & Answers

What did FDA clear under K260771?

K260771 is the FDA 510(k) for TruSelect 2.6 Microcatheter, submitted by Boston Scientific Corporation. FDA's decision date was May 15, 2026, under product code KRA (Catheter, Continuous Flush).

Who makes the TruSelect 2.6 Microcatheter?

Boston Scientific Corporation, based in Marborough, MA, is the applicant of record for K260771.

How long did the K260771 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on May 15, 2026, 67 days later.

← All decisions in May 2026