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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

510(k)

Vantis Vascular clears a 6F CrossFAST under K262817

MedDevice Startups Staff · Oct 13 · 2 min read · Via PR Newswire

FDA cleared a 6 French model of the Vantis Vascular CrossFAST advanced delivery system on September 18, 2026, under K262817. The San Jose company announced the clearance on October 13 and will launch the model in November, alongside the 5.5F version it has sold since January 2025. The new model carries a larger lumen and a shorter distal tip.

CrossFAST pairs an inner monorail microcatheter with an outer delivery catheter so both advance together, which Vantis calls DuoPRO Interlocking Technology. The indication covers use with guide catheters to reach discrete regions of the coronary or peripheral vasculature and to help place interventional devices. A second size on a platform the company already cleared is the cheaper 510(k) to file, because the predicate is its own device and most of the bench testing repeats.

Questions & Answers

What did Vantis Vascular get FDA clearance for in October 2026?

Vantis Vascular announced on October 13, 2026 that FDA cleared a 6 French model of its CrossFAST advanced delivery system under K262817. The clearance was granted September 18, 2026.

What is the Vantis Vascular CrossFAST system?

CrossFAST is an integrated microcatheter delivery system for complex percutaneous coronary intervention. It locks an inner monorail microcatheter to an outer delivery catheter so the two advance as one unit.

When will the 6F CrossFAST model be available?

Vantis Vascular said the 6F CrossFAST model launches in November 2026, alongside the 5.5F model it has sold in the United States since January 2025.

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