FDA 510(k) Application Details - K242495

Device Classification Name Tube, Tracheal (W/Wo Connector)

  More FDA Info for this Device
510(K) Number K242495
Device Name Tube, Tracheal (W/Wo Connector)
Applicant Teleflex Medical
3015 Carrington Mills Blvd
Morrisville, NC 27560 US
Other 510(k) Applications for this Company
Contact Irma Govea
Other 510(k) Applications for this Contact
Regulation Number 868.5730

  More FDA Info for this Regulation Number
Classification Product Code BTR
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/22/2024
Decision Date 04/29/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242495


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact