The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Endobronchial Twin Lumen Tube.
| Device ID | K834565 |
| 510k Number | K834565 |
| Device Name: | ENDOBRONCHIAL TWIN LUMEN TUBE |
| Classification | Tube, Bronchial (w/wo Connector) |
| Applicant | PORTEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTS |
| CFR Regulation Number | 868.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-28 |
| Decision Date | 1984-01-17 |