K897046 is an FDA 510(k) clearance for the LASER RESISTANT TRACHEAL TUBE. This device is classified as a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II - Special Controls, product code CBI).
Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on March 23, 1990, 95 days after receiving the submission on December 18, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5740.
| 510(k) Number | K897046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1989 |
| Decision Date | March 23, 1990 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5740 |