Route 92 Medical’s FreeClimb 46 Catheter with Tenzing 4 Cleared by FDA 

September 28, 2026—Route 92 Medical, Inc. announced FDA 510(k) clearance for the FreeClimb 46 catheter with Tenzing 4. The two components are engineered as an integrated system to provide neurovascular access.

According to the company, the FreeClimb 46 system joins FreeClimb 54, 70, and 88 and complements the HiPoint 70 and HiPoint 88 systems, which also feature the company’s Monopoint single-operator system.

All Route 92 access and aspiration catheters are powered by custom-sized Tenzing delivery catheters, which enable atraumatic, precise, and controlled access through neurovascular anatomy for the treatment of complex neurovascular diseases, noted Route 92 Medical.

Matthew D. Alexander, MD, Medical Director of Neurointerventional Radiology at Sutter Medical Center in Sacramento, California, commented on the new system in the company’s press release.

“In neurovascular intervention, access is critical,” stated Dr. Alexander. “Tenzing supports consistent navigation through even the most challenging cases, allowing us to reach the anatomy we need to treat. The FreeClimb 46 with Tenzing 4 expands Route 92’s catheter technologies to smaller and more distal vessels, where the clinical need is large and accurate delivery is critical to achieving the best outcomes for my patients. I look forward to bringing this next level of neurovascular access into my practice.”