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FDA 510(k) Application Details - K223130
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K223130
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
Covidien
6135 Gunbarrel Avenue
Boulder, CO 80301 US
Other 510(k) Applications for this Company
Contact
Anila Tarte
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
10/03/2022
Decision Date
08/30/2023
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
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