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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 / May 2026 / K253359

510(k) cleared

Zenith Distal Access Long Sheath

Suzhou Zenith Vascular SciTech Limited · May 22, 2026 · K253359

FDA cleared the Zenith Distal Access Long Sheath from Suzhou Zenith Vascular SciTech Limited on May 22, 2026 under K253359, a traditional 510(k). The device falls under product code QJP, Catheter, Percutaneous, Neurovasculature, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 30, 2025. The decision came 234 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Suzhou Zenith Vascular SciTech Limited has 2 other decisions in the tracker over the last 12 months: K252707 (Zenith Aspiration Catheter; Disposable Aspiration Tubing Set), K252317 (Zenith Micro Guidewire).

Questions & Answers

What did FDA clear under K253359?

K253359 is the FDA 510(k) for Zenith Distal Access Long Sheath, submitted by Suzhou Zenith Vascular SciTech Limited. FDA's decision date was May 22, 2026, under product code QJP (Catheter, Percutaneous, Neurovasculature).

Who makes the Zenith Distal Access Long Sheath?

Suzhou Zenith Vascular SciTech Limited, based in Suzhou, is the applicant of record for K253359.

How long did the K253359 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on May 22, 2026, 234 days later.

← All decisions in May 2026

Sources