21 CFR 868.6810 — Catheters, Suction, Tracheobronchial

Anesthesiology (AN) · Part 868 Subpart G—Miscellaneous · § 868.6810

Identification

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
BSYCatheters, Suction, Tracheobronchial1116
OFOAirway Suction Kit10
OFRTracheobronchial Suction Catheter Kit10
OFSTracheal Suction Set10
OYINon-Bronchoscopic Bronchoalveolar Lavage Catheter11
Innolitics

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