DeviceClearance

Product code CBI— Anesthesiology

Chartis Precision Catheter

Classification name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device class
Class 2
Regulation
21 CFR 868.5740
Advisory panel
Anesthesiology
Total cleared
34
First cleared
Most recent

Market context for product code CBI

FDA has cleared 34 devices under product code CBI between 1985 and 2026, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code CBI

Adverse events under product code CBI

product code CBI
Death
4
Malfunction
594
Total
598

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code CBI

Data sourced from openFDA. This site is unofficial and independent of the FDA.