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The Introducer Sheath with hemostasis valve is indicated for patients requiring introduction of catheters. It is intended for the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ Catheter.

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This document does not contain information about acceptance criteria, device performance, ground truth, or study details such as sample size, expert qualifications, or adjudication methods for a medical device.

The provided text is a 510(k) summary for the Heartport® Introducer Sheath from 1997. It explicitly states that "Performance testing of the subject device was not deemed necessary based on equivalence to the predicate device." This means that no specific performance study was conducted to establish acceptance criteria for the new device as its safety and effectiveness were established by demonstrating substantial equivalence to an already marketed predicate device (Heartport® Endoarterial Return™ Cannula).

Therefore, I cannot fulfill the request to provide the tables and information requested, as it is not present in the provided text.

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