Search Results

The Pediatric Central Venous Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs, for blood sampling, and for central venous pressure monitoring.

The Pediatric Central Venous Catheter consists of radiopaque catheter with a flexible soft tapered tip, hub junction, moveable suture wings, extension tubing with removable slide clamps and proximal rigid luer taper hubs. The catheter will be available in sizes ranging from 4 F to 5.5 F, with a double or triple lumen, and useable lengths of 3-1/8" to 8".

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for a Pediatric Central Venous Catheter Kit, which focuses on demonstrating substantial equivalence to a predicate device, rather than presenting detailed performance study results against predefined acceptance criteria. This type of submission relies on comparative analysis of design, materials, and intended use with existing legally marketed devices.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details.

Ask a specific question about this device