The clearance was granted under K262817 on September 18, 2026. The new 6F model will be commercially available in November alongside the existing 5.5F model, giving physicians two CrossFAST options based on procedural needs.
The 6F CrossFAST features a larger lumen designed to accommodate a broader range of interventional devices, including intravascular ultrasound (IVUS) and intravascular lithotripsy (IVL) used in complex percutaneous coronary intervention (PCI), along with a shorter distal tip. Both models build on the integrated design and deliverability of CrossFAST, which is engineered to help interventional cardiologists navigate challenging anatomies. CrossFAST is intended to be used with guide catheters to access discrete regions of the coronary and peripheral vasculature and facilitate placement of interventional devices, and has been commercially available in the United States since January 2025. The platform is powered by DuoPRO Interlocking Technology, which couples an inner monorail microcatheter with an outer delivery catheter, allowing the system to advance as one unit.