K133173 is an FDA 510(k) clearance for the RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET. This device is classified as a Tube Tracheostomy And Tube Cuff (Class II - Special Controls, product code JOH).
Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on May 23, 2014, 218 days after receiving the submission on October 17, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.
| 510(k) Number | K133173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2013 |
| Decision Date | May 23, 2014 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JOH — Tube Tracheostomy And Tube Cuff |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5800 |