K030792 is an FDA 510(k) clearance for the BARD ENDOTRACHEAL TUBE, CUFFED. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on November 14, 2003, 247 days after receiving the submission on March 12, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K030792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2003 |
| Decision Date | November 14, 2003 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTR — Tube, Tracheal (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |