Penumbra System (Reperfusion Catheter RED 72)

The Penumbra System (Reperfusion Catheter RED 72) is a catheter-based device designed to remove blood clots and restore blood flow in the brain using aspiration. It is indicated for revascularization of patients with acute ischemic stroke caused by large vessel occlusion in the internal carotid, middle cerebral (M1 and M2 segments), basilar, and vertebral arteries within 8 hours of symptom onset, for patients ineligible for or who failed thrombolytic drug therapy.

The subject device is identical in all key parameters to the predicate: same materials (stainless steel, PTFE, polyurethane, polyether block amide, nylon 12, nitinol, platinum/iridium with a differing polyether block amide composition), same dimensions (0.072 in. minimum ID, 0.085 in. maximum OD, 30 cm distal flex and coating lengths, effective lengths of 115-132 cm), same accessories (peelable sheath, shaping mandrel, rotating hemostasis valve, plus optional SENDit Technology), and same sterilization method (ethylene oxide).

ISO 10993-1 (biocompatibility), ISO 11135+A1 (sterilization), ISO 10993-7 (sterilization biocompatibility), USP standards, 21 CFR Part 58 (Good Laboratory Practices), and ASTM F2888-19 (platelet and leukocyte count).

The subject device has identical intended use, operating principle, design concept, and fundamental technology as the predicate device (K211654). All design verification tests met acceptance criteria, including dimensional specs, friction, radiopacity, simulated use, and mechanical properties. Biocompatibility testing demonstrated non-cytotoxic, non-sensitizing, and non-irritating properties comparable to the predicate; hemocompatibility results were similar to or comparable with the predicate device. The minor material composition change (differing polyether block amide) does not raise new safety or effectiveness questions because all biocompatibility and performance data met established requirements. No clinical studies were required since bench and biocompatibility testing were sufficient for verification.