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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 / K262165

510(k) cleared

FARADRIVE Steerable Sheath (M004PF21M402)

Boston Scientific Corporation · Jul 24, 2026 · K262165

FDA cleared the FARADRIVE Steerable Sheath (M004PF21M402) from Boston Scientific Corporation on Jul 24, 2026 under K262165, a special 510(k). The device falls under product code DRA, Catheter, Steerable, regulated at 21 CFR 870.1280 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 26, 2026. The decision came 28 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), K262462 (TheraSphere 360 Y-90 Management Platform), K261978 (WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System).

Questions & Answers

What did FDA clear under K262165?

K262165 is the FDA 510(k) for FARADRIVE Steerable Sheath (M004PF21M402), submitted by Boston Scientific Corporation. FDA's decision date was Jul 24, 2026, under product code DRA (Catheter, Steerable).

Who makes the FARADRIVE Steerable Sheath (M004PF21M402)?

Boston Scientific Corporation, based in Saint Paul, MN, is the applicant of record for K262165.

How long did the K262165 review take?

FDA received the submission on Jun 26, 2026 and issued its decision on Jul 24, 2026, 28 days later.

← All decisions in July 2026