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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 / K252309

510(k) cleared

PerQseal Introducers

Vivasure Medical Limited · Oct 23, 2025 · K252309

FDA cleared the PerQseal Introducers from Vivasure Medical Limited on Oct 23, 2025 under K252309, a traditional 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 Jul 24, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Vivasure Medical Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252309?

K252309 is the FDA 510(k) for PerQseal Introducers, submitted by Vivasure Medical Limited. FDA's decision date was Oct 23, 2025, under product code DYB (Introducer, Catheter).

Who makes the PerQseal Introducers?

Vivasure Medical Limited, based in Galway, is the applicant of record for K252309.

How long did the K252309 review take?

FDA received the submission on Jul 24, 2025 and issued its decision on Oct 23, 2025, 91 days later.

← All decisions in October 2025