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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 / K260012

510(k) cleared

UltraScore Focused Force PTA Balloon

Bard Peripheral Vascular, Inc. · Feb 4, 2026 · K260012

FDA cleared the UltraScore Focused Force PTA Balloon from Bard Peripheral Vascular, Inc. on Feb 4, 2026 under K260012, a special 510(k). The device falls under product code PNO, Catheter, Percutaneous, Cutting/Scoring, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 5, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Bard Peripheral Vascular, Inc. has 2 other decisions in the tracker over the last 12 months: K262571 (EnCor EnCompass Breast Biopsy and Tissue Removal System), K252681 (EnCor EnCompass Breast Biopsy and Tissue Removal System).

Questions & Answers

What did FDA clear under K260012?

K260012 is the FDA 510(k) for UltraScore Focused Force PTA Balloon, submitted by Bard Peripheral Vascular, Inc.. FDA's decision date was Feb 4, 2026, under product code PNO (Catheter, Percutaneous, Cutting/Scoring).

Who makes the UltraScore Focused Force PTA Balloon?

Bard Peripheral Vascular, Inc., based in Tempe, AZ, is the applicant of record for K260012.

How long did the K260012 review take?

FDA received the submission on Jan 5, 2026 and issued its decision on Feb 4, 2026, 30 days later.

← All decisions in February 2026

Sources