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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 / April 2026 / K260195

510(k) cleared

Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae

Medtronic, Inc. · Apr 23, 2026 · K260195

FDA cleared the Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae from Medtronic, Inc. on Apr 23, 2026 under K260195, a special 510(k). The device falls under product code DWF, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, regulated at 21 CFR 870.4210 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 22, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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), K253203 (Retrograde Coronary Sinus Perfusion Cannulae).

Questions & Answers

What did FDA clear under K260195?

K260195 is the FDA 510(k) for Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae, submitted by Medtronic, Inc.. FDA's decision date was Apr 23, 2026, under product code DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass).

Who makes the Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae?

Medtronic, Inc., based in Mounds View, MN, is the applicant of record for K260195.

How long did the K260195 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on Apr 23, 2026, 91 days later.

← All decisions in April 2026