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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 / October 2025 / K251603

510(k) cleared

Tigertriever 17 Ultra Revascularization Device

Rapid Medical Ltd. · Oct 6, 2025 · K251603

FDA cleared the Tigertriever 17 Ultra Revascularization Device from Rapid Medical Ltd. on Oct 6, 2025 under K251603, 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 May 27, 2025. The decision came 132 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), K253062 (Tigertriever 25 Revascularization Device).

Questions & Answers

What did FDA clear under K251603?

K251603 is the FDA 510(k) for Tigertriever 17 Ultra Revascularization Device, submitted by Rapid Medical Ltd.. FDA's decision date was Oct 6, 2025, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Tigertriever 17 Ultra Revascularization Device?

Rapid Medical Ltd., based in Yokneam, is the applicant of record for K251603.

How long did the K251603 review take?

FDA received the submission on May 27, 2025 and issued its decision on Oct 6, 2025, 132 days later.

← All decisions in October 2025

Sources