K160542 is an FDA 510(k) clearance for the 5.0 Fr Arndt Endobronchial Blocker Set. This device is classified as a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II - Special Controls, product code CBI).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 2, 2016, 158 days after receiving the submission on February 26, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5740.
| 510(k) Number | K160542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2016 |
| Decision Date | August 02, 2016 |
| Days to Decision | 158 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5740 |