510(k) K242495

LMA Fastrach ETT SU by Teleflex Medical — Product Code BTR

K242495 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "LMA Fastrach ETT SU". The FDA issued a decision of Substantially Equivalent on April 29, 2025. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730. Teleflex Medical has at least 10 other 510(k) clearances on record.