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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 / October 2025 / K253399

510(k) cleared

Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter

Volcano Corporation (Dba Philips Image Guided Therapy Device · Oct 28, 2025 · K253399

FDA cleared the Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter from Volcano Corporation (Dba Philips Image Guided Therapy Device on Oct 28, 2025 under K253399, a special 510(k). The device falls under product code OBJ, Catheter, Ultrasound, Intravascular, regulated at 21 CFR 870.1200 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 30, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Volcano Corporation (Dba Philips Image Guided Therapy Device in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253399?

K253399 is the FDA 510(k) for Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter, submitted by Volcano Corporation (Dba Philips Image Guided Therapy Device. FDA's decision date was Oct 28, 2025, under product code OBJ (Catheter, Ultrasound, Intravascular).

Who makes the Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter?

Volcano Corporation (Dba Philips Image Guided Therapy Device, based in San Diego, CA, is the applicant of record for K253399.

How long did the K253399 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 28, 2025, 28 days later.

← All decisions in October 2025