(27 days)
SILICONE FOLEY CATHETER WITH TS, 6FR, intended for urological use only. TSC indicated for drainage of the urinary bladder and simultaneous monitoring of temperature.
Not Found
This document is a 510(k) premarket notification FDA approval letter for a SILICONE FOLEY CATHETER WITH TS, 6FR, (TSC). It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval letter based on substantial equivalence, not a performance study report.
Therefore, I cannot provide the requested information from 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.