K091761 is an FDA 510(k) clearance for the TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT. This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on October 29, 2009, 135 days after receiving the submission on June 16, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K091761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2009 |
| Decision Date | October 29, 2009 |
| Days to Decision | 135 days |
| Submission Type | Abbreviated |
| 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 |