Search Results

The AngioDynamics, Inc. DuraMax™ Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis.

It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

Alternative insertion sites include the subclavian vein as required.

Catheters greater than 40cm are intended for femoral vein insertion.

This catheter is indicated for > 30 days long-term placement.

Not Found

This document is a 510(k) premarket notification for a hemodialysis catheter. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The FDA letter is a response to the submission, not a study report. The document indicates that there are "No Established" performance standards for this device (Section j).

Therefore, I cannot provide the requested information from the given text. It describes the device, its classification, and equivalency to other devices but does not include details on formal acceptance criteria or performance studies of the type requested (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

Ask a specific question about this device