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The Heartport Endovascular Cardiopulmonary Bypass Systems are indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass and an arrested heart. The system consists of a set of catheters, cannulae and accessories that permits a patient to be maintained on cardiopulmonary bypass and the patient's heart to be arrested without the need for a median sternotomy.

The Heartport Endovascular Cardiopulmonary Bypass Systems are composed of the following commercially available bypass catheters, cannulae and accessories: Heartport Endoaortic Clamp, Heartport Endopulmonary Vent, Heartport Endoarterial Return Cannula, Medtronic DLP Venous Drainage Cannula or a substantially equivalent Heartport manufactured device. The Heartport Endovascular Antegrade/Retrograde Cardiopulmonary Bypass System consists of the above Antegrade Kit in addition to: Heartport Endosinus Catheter.

This document (K962858) does not contain information regarding acceptance criteria, device performance, study design, or ground truth establishment. This 510(k) summary is for the 'Heartport Endovascular Cardiopulmonary Bypass Systems' and primarily focuses on its intended use and comparison to predicate devices, stating "There are no changes from the predicate devices other than the shelf packaging and its label." This indicates that the device is substantially equivalent to previously cleared devices, and detailed performance studies are not presented in this summary.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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