APRO 55 Swift Catheter and Alembic Aspiration Tubing

The APRO 55 Swift Catheter is a single-lumen, braid and coil reinforced catheter designed to remove blood clots from intracranial vessels using aspiration. It is used with an aspiration pump and Alembic Aspiration Tubing to treat acute ischemic stroke patients with large vessel occlusion within 8 hours of symptom onset who are ineligible for or have failed thrombolytic therapy.

The subject device is identical to the predicate device (K232971) in all technological aspects: same materials (nylon hub, cyanoacrylate adhesive, stainless steel braid/coil shaft, hydrophilic coating), same dimensions (0.066 inch OD, 0.055 inch ID, 125/137 cm lengths), same sterilization method (ethylene oxide), and same principle of operation. The only difference is the packaging configuration, which uses a coiled polyethylene dispenser tube and hoop coil similar to the reference device K243287.

ISO 11135 (sterilization assurance level verification), ISO 10993-1 (biocompatibility evaluation for externally communicating devices with circulating blood contact ≤24 hours), and FDA guidance on biological evaluation of medical devices.

Substantial equivalence is established because the subject device uses identical materials, manufacturing methods, sterilization processes, and performance specifications as the predicate device K232971. The only change is packaging configuration, and sterility and shelf-life testing confirmed the packaging remains functional for the labeled expiration date. Since design and materials are unchanged from predicate and reference devices for which biocompatibility testing was already completed, no new safety or effectiveness questions arise from this change.