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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
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