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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: K262151 (SpaceOAR Flex System), K262460 (Rezum System), K261153 (LithoVue Elite Digital Flexible Ureteroscope System), K253692 (AVVIGO+ Multi-Modality Guidance 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