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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 3 other decisions in the tracker over the last 12 months: K253146 (Hyperdrive 35 Guidewire), K260617 (Tigertriever 13 Ultra Revascularization Device), K254006 (Drivewire 35 Guidewire).

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