FDA 510(k) Application Details - K233341

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

  More FDA Info for this Device
510(K) Number K233341
Device Name Tube, Tracheal (W/Wo Connector)
Applicant Covidien LLC
6135 Gunbarrel Avenue
Boulder, CO 80301 US
Other 510(k) Applications for this Company
Contact Stephanie Reneau
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 09/29/2023
Decision Date 05/20/2024
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 K233341


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