510(k) K241451

Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) by Teleflex Incorporated — Product Code BTR

K241451 is an FDA 510(k) premarket notification submitted by Teleflex Incorporated for the device "Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)". The FDA issued a decision of Substantially Equivalent on February 11, 2025. The device falls under product code BTR (Tube, Tracheal (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2025
Date Received
May 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