Raptor Aspiration Catheter; Balt Aspiration Tubing Set

The Raptor Aspiration Catheter is a single-lumen catheter with variable stiffness used to remove blood clots from brain vessels in acute ischemic stroke patients. It connects to an aspiration pump via the Balt Aspiration Tubing Set to apply suction. The device is indicated for patients with large vessel occlusions in the brain who are ineligible for or have failed thrombolytic therapy.

The Raptor has smaller inner (0.038–0.054 inches) and outer diameters (0.062–0.074 inches proximal, 0.051–0.067 inches distal) compared to the predicate ZOOM, with similar hydrophilic coating and materials. It uses the same Balt Aspiration Tubing Set and Introducer Sheath as the reference Next Generation device. Effective lengths range from 145–160 cm and 125–150 cm, similar to predicate dimensions.

ISO 10993-1 (biocompatibility), ISO 10555-1 (catheter testing), ISO 80369-7 (hub compatibility), ISO 11135 (ethylene oxide sterilization), ASTM F1980 (accelerated aging), and IEC 60601-1 (electrical safety for the pump) were cited as test standards.

The Raptor is substantially equivalent because it shares the same intended use (acute ischemic stroke revascularization via aspiration thrombectomy), uses identical materials and manufacturing methods to the reference device (Next Generation Catheter), and demonstrates comparable performance in bench testing including clot retrieval, tip buckling, torque strength, and lumen collapse. Dimensional and design differences are minor and do not raise new safety or effectiveness questions; biocompatibility testing from the reference device adequately covers this device given the comparative surface assessment showed no significant differences.