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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 / K261012

510(k) cleared

OptiMap Catheter - 60mm (OPTI-CATH2-60)

Cortex, Inc. · Apr 23, 2026 · K261012

FDA cleared the OptiMap Catheter - 60mm (OPTI-CATH2-60) from Cortex, Inc. on Apr 23, 2026 under K261012, a special 510(k). The device falls under product code MTD, Catheter, Intracardiac Mapping, High-Density Array, regulated at 21 CFR 870.1220 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 27, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Cortex, Inc. has one other decision in the tracker over the last 12 months: K253205 (OptiMap Catheter - 50mm (OPTI-CATH2-50)).

Questions & Answers

What did FDA clear under K261012?

K261012 is the FDA 510(k) for OptiMap Catheter - 60mm (OPTI-CATH2-60), submitted by Cortex, Inc.. FDA's decision date was Apr 23, 2026, under product code MTD (Catheter, Intracardiac Mapping, High-Density Array).

Who makes the OptiMap Catheter - 60mm (OPTI-CATH2-60)?

Cortex, Inc., based in Santa Clara, CA, is the applicant of record for K261012.

How long did the K261012 review take?

FDA received the submission on Mar 27, 2026 and issued its decision on Apr 23, 2026, 27 days later.

← All decisions in April 2026

Sources