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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 / January 2026 / K253511

510(k) cleared

Concerto Versa Detachable Coil

Medtronic, Inc. · Jan 14, 2026 · K253511

FDA cleared the Concerto Versa Detachable Coil from Medtronic, Inc. on Jan 14, 2026 under K253511, a traditional 510(k). The device falls under product code KRD, Device, Vascular, For Promoting Embolization, regulated at 21 CFR 870.3300 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 5, 2025. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic, Inc. has 8 other decisions in the tracker over the last 12 months: K261335 (VitalFlow Set with Balance Biosurface), K261866 (Concerto Versa Detachable Coil), K253530 (Trexon Monofilament Synthetic Absorbable Suture), K260195 (Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae).

Questions & Answers

What did FDA clear under K253511?

K253511 is the FDA 510(k) for Concerto Versa Detachable Coil, submitted by Medtronic, Inc.. FDA's decision date was Jan 14, 2026, under product code KRD (Device, Vascular, For Promoting Embolization).

Who makes the Concerto Versa Detachable Coil?

Medtronic, Inc., based in Plymouth, MN, is the applicant of record for K253511.

How long did the K253511 review take?

FDA received the submission on Nov 5, 2025 and issued its decision on Jan 14, 2026, 70 days later.

← All decisions in January 2026