# K162729: Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Aug 11, 2017 after 316 days
- Product code: BSR (Stylet, Tracheal Tube)
- Device class: 1
- Regulation: 21 CFR 868.5790
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K862347 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862347: Endotracheal Tube, Accessory, Sheridan Catheter Corp. (1986) Summary page 7.

## Indications for use
The Cook Airway Exchange Catheter is intended for endotracheal tube exchange in adult and pediatric patients. The 8 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 3 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 8 French catheter is recommended for patients older than 1 month of age. The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age. The 14 French catheter is recommended for placement of an 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 2 years of age. The 19 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 7 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 19 French catheter is recommended for patients older than 12 years of age. The Cook Airway Exchange Catheter - Extra-Firm with Soft Tip is intended for endotracheal tube exchange in adult and pediatric patients. The 11 French catheter is recommended for placement of an endotracheal tube with an inner diameter of 4 mm or larger. When used for high-pressure oxygenation with a Luer Lock connector, the 11 French catheter is recommended for patients older than 2 years of age. The 14 French catheter is recommended for placement of an 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 2 years of age. The Arndt Airway Exchange Catheter Set is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients. The product may be used for emergency, urgent, and elective airway management. The 14 French catheter is recommended for placement of an endotracheal tube or a supraglottic airway device 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. The Aintree Intubation Catheter is intended for exchange of a supraglottic airway device (SAD) to an endotracheal tube (ETT) under bronchoscopic assistance, and for ETT exchange in adult and pediatric patients. The 19 French catheter is recommended for use with a supraglottic airway device and placement of a single-lumen endotracheal tube with an inner diameter of 7 mm or larger. When used for high-pressure oxygenation with a Luer lock connector, the 19 French catheter is recommended for patients older than 12 years of age.

Source page: https://510kreport.com/device/K162729
Methodology: https://510kreport.com/methodology