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The Tracker / August 2026 / K260617

510(k) cleared

Tigertriever 13 Ultra Revascularization Device

Rapid Medical Ltd. · Aug 28, 2026 · K260617

FDA cleared the Tigertriever 13 Ultra Revascularization Device from Rapid Medical Ltd. on Aug 28, 2026 under K260617, 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 Feb 25, 2026. The decision came 184 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Rapid Medical Ltd. has 3 other decisions in the tracker over the last 12 months: K254006 (Drivewire 35 Guidewire), K253062 (Tigertriever 25 Revascularization Device), K251603 (Tigertriever 17 Ultra Revascularization Device).

Questions & Answers

What did FDA clear under K260617?

K260617 is the FDA 510(k) for Tigertriever 13 Ultra Revascularization Device, submitted by Rapid Medical Ltd.. FDA's decision date was Aug 28, 2026, under product code NRY (Catheter, Thrombus Retriever).

Who makes the Tigertriever 13 Ultra Revascularization Device?

Rapid Medical Ltd., based in Yokneam, is the applicant of record for K260617.

How long did the K260617 review take?

FDA received the submission on Feb 25, 2026 and issued its decision on Aug 28, 2026, 184 days later.

← All decisions in August 2026

Sources