HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)

The HydroPICC 4Fr Single Lumen Marked catheter is a percutaneous intravascular catheter indicated for short- or long-term peripheral access to the central venous system. It is used for intravenous therapy including fluid, medication, and nutrient administration; blood sampling; central venous pressure monitoring; and power injection of contrast media at a maximum flow rate of 5.0 ml/s.

The device is a radiopaque hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in catheter manufacturing. It has the same design, material, chemical composition, and principle of operation as the predicate device, with the form, fit, and function unchanged from previous clearances.

Not stated in this summary.

The device is substantially equivalent because it possesses identical technological characteristics to the predicate HydroPICC (K193015), including design and materials. The only modification is an increase in the power injection rating from the predicate to 5.0 ml/s, which is supported by in vitro performance data demonstrating the device will function as intended under this modified specification. Since the device maintains the same intended use, addresses the same patient population and clinical needs, and has demonstrated safety and effectiveness with the new power injection rating, it meets the criteria for substantial equivalence.