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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Tracheal Tube, Inflatable
510(k) Number K242642
Device Name CuffTrek
Applicant
Shanghai Longmann Tech Co., Ltd.
Rm. 2106, #3, Ln.791
Lingling Rd.
Shanghai,  CN 200030
Applicant Contact Yexue Gao
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number868.5750
Classification Product Code
BSK  
Date Received09/03/2024
Decision Date 03/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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