K080339 is an FDA 510(k) clearance for the MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF). This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Medsource International, LLC (Indianapolis, US). The FDA issued a Cleared decision on October 27, 2008, 262 days after receiving the submission on February 8, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K080339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2008 |
| Decision Date | October 27, 2008 |
| Days to Decision | 262 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 |