K101721 is an FDA 510(k) clearance for the WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA. This device is classified as a Tube, Tracheostomy (w/wo Connector) (Class II - Special Controls, product code BTO).
Submitted by Regulatory and Marketing Services, Inc. (Apollo Beach, US). The FDA issued a Cleared decision on March 24, 2011, 279 days after receiving the submission on June 18, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K101721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2010 |
| Decision Date | March 24, 2011 |
| Days to Decision | 279 days |
| Submission Type | Special |
| 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 |