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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 / K254236

510(k) cleared

Peel-Away Introducer Sheath

VascuTech Medical, LLC · Feb 9, 2026 · K254236

FDA cleared the Peel-Away Introducer Sheath from VascuTech Medical, LLC on Feb 9, 2026 under K254236, 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 Dec 29, 2025. The decision came 42 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for VascuTech Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254236?

K254236 is the FDA 510(k) for Peel-Away Introducer Sheath, submitted by VascuTech Medical, LLC. FDA's decision date was Feb 9, 2026, under product code DYB (Introducer, Catheter).

Who makes the Peel-Away Introducer Sheath?

VascuTech Medical, LLC, based in Oaks, PA, is the applicant of record for K254236.

How long did the K254236 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Feb 9, 2026, 42 days later.

← All decisions in February 2026