pREBOA-PRO Catheter

The pREBOA-PRO Catheter is a large vessel occlusion catheter designed for temporary partial or complete blockage of blood vessels and blood pressure monitoring, particularly for emergency hemorrhage control. It features a semi-compliant balloon, dual lumen design for pressure monitoring and balloon inflation, an in-line safety valve, and atraumatic distal tip, and is compatible with standard 7 Fr introducer sheaths.

The modified device is physically identical to its predicate (K200459) in all hardware aspects. The only differences are in the Instructions for Use: clarified indications to specify partial or complete occlusion capability, added reference values for above and below balloon aortic blood pressure monitoring, and a new precaution statement regarding maximum occlusion durations supported by available clinical and animal data.

Not stated in this summary. The document references bench test results demonstrating ability to achieve and maintain targeted below-balloon blood pressure (≥20 mmHg) for 2 hours of partial occlusion, but does not cite specific ISO, IEC, or ASTM standards.

The device is substantially equivalent because it is physically and mechanically identical to the predicate device cleared under K200459. The labeling modifications do not represent design or functional changes; they merely clarify the existing capability for partial occlusion and provide clinically relevant blood pressure reference values and duration precautions based on consensus algorithms, swine studies, and limited clinical experience. These are instructional refinements to communicate safe use of an unchanged device, not material alterations to its intended function or performance characteristics.