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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 / August 2026 / K260751

510(k) cleared

35 Helix Guidewire

Piraeus Medical, Inc. · Aug 27, 2026 · K260751 · In the directory

FDA cleared the 35 Helix Guidewire from Piraeus Medical, Inc. on Aug 27, 2026 under K260751, a traditional 510(k). The device falls under product code MOF, Guide, Wire, Catheter, Neurovasculature, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 6, 2026. The decision came 174 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Piraeus Medical, Inc. has one other decision in the tracker over the last 12 months: K262277 (70 NeuGlide Catheter).

Questions & Answers

What did FDA clear under K260751?

K260751 is the FDA 510(k) for 35 Helix Guidewire, submitted by Piraeus Medical, Inc.. FDA's decision date was Aug 27, 2026, under product code MOF (Guide, Wire, Catheter, Neurovasculature).

Who makes the 35 Helix Guidewire?

Piraeus Medical, Inc., based in Maple Grove, MN, is the applicant of record for K260751. The company is listed in the MedDevice Startups directory.

How long did the K260751 review take?

FDA received the submission on Mar 6, 2026 and issued its decision on Aug 27, 2026, 174 days later.

← All decisions in August 2026

Sources

In the startup directory

Piraeus Medical

Neurology & Neurotech · Maple Grove, MN