510(k) K241451
Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) by
Teleflex Incorporated
— Product Code BTR
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