FDA Radiology AI Devices

The Zoom 7X Catheter, along with the Zoom Aspiration Tubing and Zoom POD Aspiration Tubing, is a sterile, single-use medical device designed to remove blood clots from large intracranial vessels in patients experiencing an acute ischemic stroke. It helps restore blood flow by aspirating the clot when connected to an aspiration pump, aiding clinicians in rapidly treating stroke and improving patient outcomes.

The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a device used to remove blood clots in patients suffering from acute ischemic stroke caused by large vessel blockages in the brain. It is used with a compatible vacuum pump to restore blood flow within 8 hours of stroke onset, helping patients who are not eligible for or have failed drug therapy. This system comprises catheters and tubing designed for safe and effective clot removal in neurovascular procedures.

The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are medical devices designed to assist in the revascularization of patients experiencing acute ischemic stroke caused by large vessel occlusions in the brain. The catheter is used alongside a compatible aspiration pump to remove blood clots from the affected neurovasculature, helping to restore blood flow. This device is intended for use within 8 hours of stroke symptom onset and for patients who have not responded to or are ineligible for thrombolytic drug therapy.

The Penumbra System (Reperfusion Catheter RED 72) is a catheter-based device designed to remove blood clots in the brain's large vessels to treat acute ischemic stroke. It uses aspiration to restore blood flow in blocked intracranial vessels during neurointerventional procedures, guided by fluoroscopy. This device helps clinicians revascularize patients who are ineligible or have failed thrombolytic drug therapy, improving stroke treatment outcomes.

The Riptide Aspiration System is a medical device designed to restore blood flow in patients suffering from acute ischemic stroke caused by intracranial large vessel occlusions. It uses continuous aspiration via specialized catheters and pumping system to remove blood clots from critical arteries in the brain, helping clinicians quickly reopen blocked vessels and potentially improve patient outcomes.

The CEREGLIDE 42 and 57 Intermediate Catheters, together with the Cerenovus Aspiration Tubing Set, are medical devices used to remove blood clots from large intracranial vessels during acute ischemic strokes. These catheters are navigated through the brain's blood vessels under fluoroscopic imaging to restore blood flow by aspirating clots, helping patients who cannot receive or have failed drug-based clot dissolving treatments.