510(k) K162729

Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip by Cook Incorporated — Product Code BSR

K162729 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip". The FDA issued a decision of Substantially Equivalent on August 11, 2017. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Cook Incorporated has at least 10 other 510(k) clearances on record.