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510(k)

Route 92 Medical clears the FreeClimb 46, the smallest catheter in its stroke line

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via Route 92 Medical press release

FDA cleared Route 92 Medical's FreeClimb 46 Catheter with Tenzing 4, the company said on September 28. The system pairs an aspiration catheter with a matched delivery catheter for neurovascular access. It extends a line that already runs FreeClimb 54, 70 and 88.

The pitch is distal reach. Route 92 builds around its Monopoint single-operator design, where a Tenzing catheter sized to the aspiration catheter carries it into smaller vessels. Matthew Alexander, medical director at Sutter Medical Center Sacramento, said Tenzing supports consistent navigation in difficult cases.

Route 92 moved its headquarters to West Jordan, Utah this year and took $50 million in growth financing in April. It counts more than 200 issued US and international patents across the portfolio. A smaller catheter inside an already cleared family is among the cheapest 510(k)s a neurovascular company can run, because the predicate is its own product and much of the bench testing carries over.

Questions & Answers

What did Route 92 Medical get FDA clearance for in September 2026?

Route 92 Medical announced clearance of the FreeClimb 46 Catheter with Tenzing 4 on September 28, 2026. It is a neurovascular access and aspiration system aimed at small, distal vessels.

What is Route 92 Medical's Tenzing technology?

Tenzing is Route 92 Medical's delivery catheter, sized to match each FreeClimb or HiPoint aspiration catheter. It uses the company's Monopoint single-operator approach to carry the larger catheter to the target.

Where is Route 92 Medical headquartered?

Route 92 Medical is headquartered in West Jordan, Utah. The company announced $50 million in growth financing in April 2026.

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