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The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and 8.0 French and a length of 16". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

This document is a 510(k) premarket notification for a Pediatric Urinary Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, much of the requested information cannot be directly extracted or is not applicable in the context of this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study endpoint. Instead, the comparison to the predicate device serves as the primary means of demonstrating safety and effectiveness. The "Proposed device" column acts as the "reported device performance" in this context, showing that its attributes match or are equivalent to the predicate.

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