K153761 is an FDA 510(k) clearance for the Emergency Transtracheal Airway Catheter. This device is classified as a Needle, Emergency Airway (Class II - Special Controls, product code BWC).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 22, 2016, 267 days after receiving the submission on December 30, 2015.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5090.
| 510(k) Number | K153761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2015 |
| Decision Date | September 22, 2016 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BWC — Needle, Emergency Airway |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5090 |