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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 / December 2025 / K252417

510(k) cleared

Amplatzer Piccolo Delivery System (9-PDS-04F-045)

ABBOTT MEDICAL · Dec 17, 2025 · K252417

FDA cleared the Amplatzer Piccolo Delivery System (9-PDS-04F-045) from ABBOTT MEDICAL on Dec 17, 2025 under K252417, a traditional 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 Aug 1, 2025. The decision came 138 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 K252417?

K252417 is the FDA 510(k) for Amplatzer Piccolo Delivery System (9-PDS-04F-045), submitted by ABBOTT MEDICAL. FDA's decision date was Dec 17, 2025, under product code DQY (Catheter, Percutaneous).

Who makes the Amplatzer Piccolo Delivery System (9-PDS-04F-045)?

ABBOTT MEDICAL, based in St. Paul, MN, is the applicant of record for K252417.

How long did the K252417 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Dec 17, 2025, 138 days later.

← All decisions in December 2025