(23 days)
The Cordis Maxi LD Large Balloon Dilatation Catheter is intended for use in the dilatation of strictures of the esophagus.
The device is an over the wire balloon catheter, with a distal balloon and a proximal hub. The balloon features two radiopaque marker bands.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The document is a 510(k) summary for the Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, a medical device for dilating esophageal strictures. It primarily focuses on demonstrating substantial equivalence to predicate devices, not on quantitative performance metrics or studies using test sets, expert ground truth, or AI.
Therefore, I cannot provide the requested information in the table format because the details are not present in the given text.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.