(195 days)
This closed suction catheter system is indicated for patients with an endotracheal tube or tracheostomy tube to suction tracheobronchial secretions. This device is indicated for single patient use only. The suction catheter should be replaced after 24 hours.
Not Found
This document is a marketing clearance letter from the FDA for the "Hi-Care Closed Suction System." It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.
Therefore, I cannot provide the requested information. The provided text is a regulatory approval document, not a clinical study report or a performance evaluation.
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.