The following data is part of a premarket notification filed by Daiken Medical Co, Ltd. with the FDA for Coopdech Endobronchial Blocker Tube.
| Device ID | K093888 |
| 510k Number | K093888 |
| Device Name: | COOPDECH ENDOBRONCHIAL BLOCKER TUBE |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | DAIKEN MEDICAL CO, LTD. 4-1-17 HONGO, BUNKYO-KU Tokyo, JP 113-0033 |
| Contact | Fumiaki Kanai |
| Correspondent | Fumiaki Kanai DAIKEN MEDICAL CO, LTD. 4-1-17 HONGO, BUNKYO-KU Tokyo, JP 113-0033 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2010-03-16 |
| Summary: | summary |