510(k) K854252
K854252 is an FDA 510(k) premarket notification submitted by Transtracheal Systems for the device "TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER". The FDA issued a decision of Substantially Equivalent (with conditions) on February 3, 1986. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. Transtracheal Systems has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- February 3, 1986
- Date Received
- October 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tracheostomy (W/Wo Connector)
- Device Class
- Class II
- Regulation Number
- 868.5800
- Review Panel
- AN
- Submission Type