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The EmboTrap II Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The EMBOTRAP III Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The EmboTrap® II and EMBOTRAP™ III Revascularization Devices are composed of a retrievable, selfexpanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. They are designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EmboTrap® II and EMBOTRAP™ III Revascularization Devices are supplied sterile and are intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

This is not an AI/ML device approval summary. The document describes a 510(k) premarket notification for a revascularization device (EmboTrap II and EMBOTRAP III) and focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing for compatibility with new microcatheters. There is no mention of an algorithm, AI, or machine learning model.

Therefore, I cannot extract the requested information regarding acceptance criteria and study proving an AI/ML device meets them, as the provided document does not pertain to such a device.

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