Search Results

THE MEDCOMP ULTRA-FLOW™ HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING ECHE 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. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.

The Medcomp Ultra-Flow™ Catheter is a 14.5F polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the clamps for ease in identification. The proposed device is a product line extension to the legally marketed device, ar identical in design and materials. The modifications include: 55cm length, Femoral insertion instructions for use.

Here's a summary of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not provide specific quantitative acceptance criteria (e.g., "recirculation rate

Ask a specific question about this device