510(k) clearance
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)
- 510(k) number
- K253063
- Applicant
- Vitaltec Corporation
- Decision date
- Sep 11, 2026
- Date received
- Sep 22, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- BTO
- Device type
- Tube, Tracheostomy (W/Wo Connector)
- Device class
- Class II
- Regulation
- 21 CFR 868.5800
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Taichung City, TW