(55 days)
In-Ka® ureteral balloon dilatation catheters are intended for:
- . Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures
- . Treatment of ureteral stenosis
The In-Ka Ureteral Balloon Dilatation Catheter is a urinary balloon catheter intended for dilation of the ureteral meatus or the ureteral canal or for treatment of ureteral stenosis. The catheter is a double lumen catheter with a balloon at the distal end and supplied in three balloon diameters ranging from 4 - 6 mm. Each 75 cm long In-Ka catheter is supplied sterile for a single use. Either a manometer or a 10cc syringe is included for balloon inflation.
This document describes the regulatory approval for the In-Ka® Ureteral Balloon Dilatation Catheters and does not provide information about an AI/ML device or its acceptance criteria. Thus, it is not possible to fill out the table and answer the questions related to AI/ML device performance and study as the provided text doesn't contain the relevant details.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).