(162 days)
The Footprint Urinary Drainage Catheter is a flexible tube intended for drainage of urine from small pediatric or Neonatal patients. This is a prescription device intended for use for less than 30 days. It is not implanted and is not a life supporting device.
Not Found
This document is a 510(k) premarket notification from the FDA regarding a urinary drainage catheter. It does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an approval letter for the device, stating it is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the provided text.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.