CoraForce Microcatheter, CoraFlex Microcatheter

The CoraForce and CoraFlex Microcatheters are single-lumen catheters designed to access coronary and peripheral blood vessels. They work with steerable guidewires to facilitate guidewire placement and exchange, enable passage of interventional devices, and allow delivery of diagnostic contrast solutions.

Both subject and predicate devices use over-the-wire percutaneous delivery, smooth inner lumens for reduced friction, polymer shafts with controlled geometries, and coiled designs for flexibility. The subject device adds a proximal spin zone for pushability, an increased distal floppy zone for trackability, and a spin-friendly strain relief with spiral design to aid torque control. The subject device also features a tapered catheter outer diameter ranging from 0.051" proximally to 0.032" distally, versus the predicate's uniform 0.032" maximum.

Not stated in this summary.

The subject microcatheters are substantially equivalent because they maintain the same fundamental design principles, indications for use, guidewire and sheath compatibility, catheter length, component materials, lubricious coating, tip configurations, sterilization method, and packaging as the predicate devices cleared under K201811. The design modifications (spin zone, floppy zone, and strain relief geometry) represent incremental improvements that do not alter the intended function or raise new safety concerns. All nonclinical bench testing—including simulated use, dimensional verification, kink resistance, torque testing, and biocompatibility—met specified criteria without raising new questions compared to the predicate.