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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 / March 2026 / K260499

510(k) cleared

Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

ABBOTT MEDICAL · Mar 13, 2026 · K260499

FDA cleared the Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 from ABBOTT MEDICAL on Mar 13, 2026 under K260499, a special 510(k). The device falls under product code DQY, Catheter, Percutaneous, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 13, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

ABBOTT MEDICAL has 8 other decisions in the tracker over the last 12 months: K262006 (EnSite X EP System), K261825 (Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter), K261631 (Amplatzer TorqVue Exchange System), K253459 (OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)).

Questions & Answers

What did FDA clear under K260499?

K260499 is the FDA 510(k) for Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80, submitted by ABBOTT MEDICAL. FDA's decision date was Mar 13, 2026, under product code DQY (Catheter, Percutaneous).

Who makes the Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80?

ABBOTT MEDICAL, based in St. Paul, MN, is the applicant of record for K260499.

How long did the K260499 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Mar 13, 2026, 28 days later.

← All decisions in March 2026