510(k) K955461
K955461 is an FDA 510(k) premarket notification submitted by VBM Medizintechnik GmbH for the device "TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).". The FDA issued a decision of Substantially Equivalent on March 19, 1997. The device falls under product code BTO (Tube, Tracheostomy (W/Wo Connector)), a Class II device regulated under 21 CFR 868.5800. VBM Medizintechnik GmbH has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1997
- Date Received
- November 29, 1995
- 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