Baxter Healthcare Corporation · Class II · Cleared Feb 28, 2025
| K-number | K242339 |
| Device name | Intravascular Extension Sets and Accessories |
| Applicant | Baxter Healthcare Corporation |
| Product code | FPA |
| Device class | Class II |
| Decision date | Feb 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.5440 |
The Intravascular Extension Sets and Accessories are single-use disposable devices designed to administer fluids from a container into a patient's vascular system through a vascular access device. The extension sets combine PVC or PE-lined tubing with components such as clamps, female Luer connectors with and without vented caps, and filters. The accessories include anti-siphon valves, back check valves, and 1.2 μm filters for use with IV sets.
The proposed devices have the same technical characteristics as the predicate devices with no changes in design, material, sterility, or chemical composition. The only modification is the removal of a caution statement on the Direction Insert related to body weight.
Not stated in this summary.
Substantial equivalence is based on identical indications for use (fluid administration through vascular access), the same intended use as the predicate K192366, and biocompatibility testing supporting the removal of the body weight caution. Since there are no changes to design, material, sterility, or chemical composition, the devices perform the same function in the same manner as the legally marketed predicate device.
View the full FDA submission: accessdata.fda.gov