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FDA 510(k) Application Details - K251499
Device Classification Name
Tube, Tracheal (W/Wo Connector)
More FDA Info for this Device
510(K) Number
K251499
Device Name
Tube, Tracheal (W/Wo Connector)
Applicant
William Cook Europe Aps
Sandet 6
Bjaeverskov 4632 DK
Other 510(k) Applications for this Company
Contact
Mie Dyrholm
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
05/15/2025
Decision Date
06/11/2025
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K251499
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