K192511 is an FDA 510(k) clearance for the Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Venner Medical (Singapore) Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on July 22, 2020, 314 days after receiving the submission on September 12, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K192511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2019 |
| Decision Date | July 22, 2020 |
| Days to Decision | 314 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTO - Tube, Tracheostomy (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |