510(k) K230269
K230269 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Ultraflex Tracheobronchial Stent System". The FDA issued a decision of Substantially Equivalent on July 14, 2023. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 2023
- Date Received
- January 31, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Tracheal, Expandable
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- AN
- Submission Type