# DEN170055: Retrograde Intubation Set

- Pathway: De Novo (Direct)
- Applicant: Cook Incorporated
- Decided: Dec 12, 2018 after 443 days
- Product code: QCX (Retrograde Intubation Set)
- Device class: 2
- Regulation: 21 CFR 868.5095
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Retrograde Intubation Set is intended to assist in intubation during difficult or emergency airway access procedures in adult and pediatric patients. The 6 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 2.5 mm or larger. The 11 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 4 mm or larger. The 14 French catheter is recommended for use with a single-lumen endotracheal tube with an inner diameter of 5 mm or larger. When used for high pressure oxygenation with a Luer Lock connector, the 14 French catheter is recommended for patients older than 12 years of age.

Source page: https://510kreport.com/device/DEN170055
Methodology: https://510kreport.com/methodology