K955461 is an FDA 510(k) clearance for the TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by VBM Medizintechnik GmbH (Roy, US). The FDA issued a Cleared decision on March 19, 1997, 476 days after receiving the submission on November 29, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K955461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1995 |
| Decision Date | March 19, 1997 |
| Days to Decision | 476 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTO - Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |