WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K261640

510(k) cleared

Merit MAK Nitinol/Gold-Tungsten Guide Wire

Merit Medical Ireland , Ltd. · Jul 13, 2026 · K261640

FDA cleared the Merit MAK Nitinol/Gold-Tungsten Guide Wire from Merit Medical Ireland , Ltd. on Jul 13, 2026 under K261640, a special 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on May 18, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Merit Medical Ireland , Ltd. has 3 other decisions in the tracker over the last 12 months: K254137 (InQwire Amplatz Guide Wire), K253847 (Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)), K251385 (InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)).

Questions & Answers

What did FDA clear under K261640?

K261640 is the FDA 510(k) for Merit MAK Nitinol/Gold-Tungsten Guide Wire, submitted by Merit Medical Ireland , Ltd.. FDA's decision date was Jul 13, 2026, under product code DQX (Wire, Guide, Catheter).

Who makes the Merit MAK Nitinol/Gold-Tungsten Guide Wire?

Merit Medical Ireland , Ltd., based in Galway, is the applicant of record for K261640.

How long did the K261640 review take?

FDA received the submission on May 18, 2026 and issued its decision on Jul 13, 2026, 56 days later.

← All decisions in July 2026