Innovative Health · Class II · Cleared Jan 7, 2026
| K-number | K250305 |
| Device name | Reprocessed Agilis NxT Steerable Introducer |
| Applicant | Innovative Health |
| Product code | PNE |
| Device class | Class II |
| Decision date | Jan 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
The Reprocessed Agilis NxT Steerable Introducer is a catheter introduction system consisting of a steerable sheath, dilator, and guidewire. It is designed to introduce cardiovascular catheters into the heart, including the left side, during treatment of cardiac arrhythmias. The device features a bi-directional steerable tip with hemostasis valve and is available in small, medium, and large curl configurations.
The reprocessed device is identical in purpose, design, materials, function, and intended use to the predicate device. It consists of a braided stainless-steel sheath covered with Pebax and Nylon, filled with barium sulfate, and includes a platinum/iridium distal marker. The reprocessing process includes removal of visible soil, decontamination, inspection, and function testing. Devices are reprocessed no more than two times and then rejected from further reprocessing.
Not stated in this summary.
Substantial equivalence is established through identical design, materials, and function to the predicate device (Agilis NxT Steerable Introducer, K251211). Bench and laboratory testing validated biocompatibility, cleaning and sterilization procedures, and functional performance across visual inspection, dimensional verification, tensile testing, deflection testing, leak testing, radiopacity, and particulate analysis. The reprocessing methodology ensures device safety and performance equivalence to the original device.
View the full FDA submission: accessdata.fda.gov