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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 / July 2026 / K261310

510(k) cleared

FlexTract Deflectable-Rotational Dilator Sheath Set

Merit Medical Systems, Inc. · Jul 27, 2026 · K261310

FDA cleared the FlexTract Deflectable-Rotational Dilator Sheath Set from Merit Medical Systems, Inc. on Jul 27, 2026 under K261310, a traditional 510(k). The device falls under product code DRE, Dilator, Vessel, For Percutaneous Catheterization, regulated at 21 CFR 870.1310 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 21, 2026. The decision came 97 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Merit Medical Systems, Inc. has 5 other decisions in the tracker over the last 12 months: K262086 (PreludeSYNC Radial Compression Device), K254073 (StatSeal Disc), K251802 (STAR RF Ablation System), K252892 (SCOUT MD Surgical Guidance System).

Questions & Answers

What did FDA clear under K261310?

K261310 is the FDA 510(k) for FlexTract Deflectable-Rotational Dilator Sheath Set, submitted by Merit Medical Systems, Inc.. FDA's decision date was Jul 27, 2026, under product code DRE (Dilator, Vessel, For Percutaneous Catheterization).

Who makes the FlexTract Deflectable-Rotational Dilator Sheath Set?

Merit Medical Systems, Inc., based in South Jordan, UT, is the applicant of record for K261310.

How long did the K261310 review take?

FDA received the submission on Apr 21, 2026 and issued its decision on Jul 27, 2026, 97 days later.

← All decisions in July 2026

Sources