510(k) K243579

AeroJet Ventilation Catheter by Pipeline Medical Products, LLC — Product Code BTR

K243579 is an FDA 510(k) premarket notification submitted by Pipeline Medical Products, LLC for the device "AeroJet Ventilation Catheter". The FDA issued a decision of Substantially Equivalent on August 13, 2025. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730.