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THE TAPE

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 / April 2026 / K260091

510(k) cleared

Aventus Introducer Sheath

Inquis Medical · Apr 13, 2026 · K260091 · In the directory

FDA cleared the Aventus Introducer Sheath from Inquis Medical on Apr 13, 2026 under K260091, 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 Jan 12, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Inquis Medical has 3 other decisions in the tracker over the last 12 months: K261105 (Powered Aventus Thrombectomy System), K262030 (Aventus Thrombectomy System), K253925 (Aventus Thrombectomy System).

Questions & Answers

What did FDA clear under K260091?

K260091 is the FDA 510(k) for Aventus Introducer Sheath, submitted by Inquis Medical. FDA's decision date was Apr 13, 2026, under product code DYB (Introducer, Catheter).

Who makes the Aventus Introducer Sheath?

Inquis Medical, based in Menlo Park, CA, is the applicant of record for K260091. The company is listed in the MedDevice Startups directory.

How long did the K260091 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Apr 13, 2026, 91 days later.

← All decisions in April 2026

Sources

In the startup directory

Inquis Medical

Cardiovascular · Menlo Park, CA