Medtronic Interventional Vascular, Inc. · Class II · Cleared Apr 23, 2026
| K-number | K253589 |
| Device name | Liberant RX Aspiration Catheter |
| Applicant | Medtronic Interventional Vascular, Inc. |
| Product code | QEZ |
| Device class | Class II |
| Decision date | Apr 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 870.5150 |
The Liberant™ RX Aspiration Catheter is a 6F Guide-compatible, sterile, single-use dual lumen catheter designed for removal of embolic material (thrombus/debris) from arterial vessels and for selective infusion of diagnostic or therapeutic agents. It supports both mechanical aspiration via pump and collection canister, and manual aspiration via syringe.
The device is 0.014" guidewire compatible with a hydrophilic coating, distal radiopaque tip marker, and proximal luer-lock port. It includes a preloaded stylet, aspiration line, two locking aspiration syringes, and filter cup. The key difference from the predicate is the addition of mechanical aspiration capability using a pump and canister as an alternative to manual syringe aspiration, while all other design, materials, manufacturing, sterilization, and shelf-life remain unchanged.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov