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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K253063
Device Name Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)
Applicant
Vitaltec Corporation
# 12, Ln. 4-30, Chyuan-Zhou Rd., Hou-Li Dist.
Taichung City,  TW 42142
Applicant Contact Joseph Chang
Correspondent
Ruscert Technology Co., Ltd.
8f., # 187, Lequn 2nd Rd., Zhongshan Dist.
Taipei City,  TW 10462
Correspondent Contact Ming-Yie Jan
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/22/2025
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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