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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 / March 2026 / K253062

510(k) cleared

Tigertriever 25 Revascularization Device

Rapid Medical Ltd. · Mar 12, 2026 · K253062

FDA cleared the Tigertriever 25 Revascularization Device from Rapid Medical Ltd. on Mar 12, 2026 under K253062, a traditional 510(k). The device falls under product code NRY, Catheter, Thrombus Retriever, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 22, 2025. The decision came 171 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Rapid Medical Ltd. has 2 other decisions in the tracker over the last 12 months: K254006 (Drivewire 35 Guidewire), K251603 (Tigertriever 17 Ultra Revascularization Device).

Questions & Answers

What did FDA clear under K253062?

K253062 is the FDA 510(k) for Tigertriever 25 Revascularization Device, submitted by Rapid Medical Ltd.. FDA's decision date was Mar 12, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Tigertriever 25 Revascularization Device?

Rapid Medical Ltd., based in Yokneam, is the applicant of record for K253062.

How long did the K253062 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Mar 12, 2026, 171 days later.

← All decisions in March 2026

Sources