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The Tracker / September 2026 / K253146

510(k) cleared

Hyperdrive 35 Guidewire

Rapid-Medical , Ltd. · Sep 18, 2026 · K253146

FDA cleared the Hyperdrive 35 Guidewire from Rapid-Medical , Ltd. on Sep 18, 2026 under K253146, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 25, 2025. The decision came 358 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Rapid-Medical , Ltd. has 4 other decisions in the tracker over the last 12 months: K260617 (Tigertriever 13 Ultra Revascularization Device), K254006 (Drivewire 35 Guidewire), K253062 (Tigertriever 25 Revascularization Device), K251603 (Tigertriever 17 Ultra Revascularization Device).

Questions & Answers

What did FDA clear under K253146?

K253146 is the FDA 510(k) for Hyperdrive 35 Guidewire, submitted by Rapid-Medical , Ltd.. FDA's decision date was Sep 18, 2026, under product code DQX (Wire, Guide, Catheter).

Who makes the Hyperdrive 35 Guidewire?

Rapid-Medical , Ltd., based in Yokneam, is the applicant of record for K253146.

How long did the K253146 review take?

FDA received the submission on Sep 25, 2025 and issued its decision on Sep 18, 2026, 358 days later.

← All decisions in September 2026

Sources