The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Sheridan Endobronchial Tubes.
| Device ID | K180253 |
| 510k Number | K180253 |
| Device Name: | Sheridan Endobronchial Tubes |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | Teleflex Medical 3015 Carrington Mills Blvd Morrisville, NC 27560 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl Teleflex Medical 3015 Carrington Mills Blvd Morrisville, NC 27560 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-30 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704617464 | K180253 | 000 |
| 34026704760092 | K180253 | 000 |
| 24026704760101 | K180253 | 000 |
| 34026704760115 | K180253 | 000 |
| 24026704760125 | K180253 | 000 |
| 24026704760156 | K180253 | 000 |
| 34026704760160 | K180253 | 000 |
| 34026704760177 | K180253 | 000 |
| 44026704617386 | K180253 | 000 |
| 44026704617393 | K180253 | 000 |
| 44026704617409 | K180253 | 000 |
| 44026704617416 | K180253 | 000 |
| 34026704617426 | K180253 | 000 |
| 44026704617447 | K180253 | 000 |
| 34026704617457 | K180253 | 000 |
| 24026704760132 | K180253 | 000 |