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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 / April 2026 / K260459

510(k) cleared

VANES Delivery System (VDS)

Zoll Respicardia, Inc. · Apr 6, 2026 · K260459

FDA cleared the VANES Delivery System (VDS) from Zoll Respicardia, Inc. on Apr 6, 2026 under K260459, 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 Feb 11, 2026. The decision came 54 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260459?

K260459 is the FDA 510(k) for VANES Delivery System (VDS), submitted by Zoll Respicardia, Inc.. FDA's decision date was Apr 6, 2026, under product code DYB (Introducer, Catheter).

Who makes the VANES Delivery System (VDS)?

Zoll Respicardia, Inc., based in Minnetonka, MN, is the applicant of record for K260459.

How long did the K260459 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Apr 6, 2026, 54 days later.

← All decisions in April 2026