(36 days)
For use as an abdominal access port during a laparoscopic procedure and the 1-way stopcock for attaching insufflation tubing to maintain pneumoperitoneal pressure.
Not Found
The provided text is a 510(k) clearance letter for a Peritoneal Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, or clinical trial data.
The letter is a regulatory approval document and not a scientific or clinical study report. Therefore, I cannot extract the requested information as it is not present in the provided text.
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.