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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 / K252766

510(k) cleared

14Fr Low Profile Introducer Kit

Abiomed, Inc. · Oct 8, 2025 · K252766

FDA cleared the 14Fr Low Profile Introducer Kit from Abiomed, Inc. on Oct 8, 2025 under K252766, a special 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 29, 2025. The decision came 40 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Abiomed, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252766?

K252766 is the FDA 510(k) for 14Fr Low Profile Introducer Kit, submitted by Abiomed, Inc.. FDA's decision date was Oct 8, 2025, under product code DYB (Introducer, Catheter).

Who makes the 14Fr Low Profile Introducer Kit?

Abiomed, Inc., based in Danvers, MA, is the applicant of record for K252766.

How long did the K252766 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Oct 8, 2025, 40 days later.

← All decisions in October 2025