510(k) K242495

LMA Fastrach ETT SU by Teleflex Medical — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2025
Date Received
August 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type