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The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

The Abbott Vascular Devices Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding stent to the biliary tree.

This document does not contain the information required to populate the fields in the request. The provided text is a 510(k) summary for a medical device (Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System) and a letter from the FDA regarding its clearance.

The content focuses on:

• Device Identification: Name, regulation, classification, product code.
• Intended Use: Palliation of malignant neoplasms in the biliary tree.
• Device Description: Delivery system and self-expanding stent.
• Substantial Equivalence Claim: To a predicate device (K031331) based on non-clinical testing.
• FDA Clearance Letter: Confirming substantial equivalence, specifying labeling limitations (e.g., safety and effectiveness for vascular use not established), and outlining general regulatory requirements.

It does not include:

• A table of acceptance criteria or performance results.
• Details of any clinical or non-clinical study design, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.

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