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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 / February 2026 / K252512

510(k) cleared

Armada 14 NC PTA Catheter

ABBOTT MEDICAL · Feb 13, 2026 · K252512

FDA cleared the Armada 14 NC PTA Catheter from ABBOTT MEDICAL on Feb 13, 2026 under K252512, a traditional 510(k). The device falls under product code LIT, Catheter, Angioplasty, Peripheral, Transluminal, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 11, 2025. The decision came 186 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K252512?

K252512 is the FDA 510(k) for Armada 14 NC PTA Catheter, submitted by ABBOTT MEDICAL. FDA's decision date was Feb 13, 2026, under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal).

Who makes the Armada 14 NC PTA Catheter?

ABBOTT MEDICAL, based in Santa Clara, CA, is the applicant of record for K252512.

How long did the K252512 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Feb 13, 2026, 186 days later.

← All decisions in February 2026