(27 days)
The Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids.
Not Found
This is a 510(k) clearance letter for a General Purpose Drainage Catheter, which is a physical medical device. The document does not describe acceptance criteria, a study proving the device meets criteria, or any AI/algorithm performance. Therefore, I cannot provide the requested information.
§ 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.