The following data is part of a premarket notification filed by Covidien with the FDA for Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube With Taperguard Cuff, Reusable Inner Cannula.
| Device ID | K150844 |
| 510k Number | K150844 |
| Device Name: | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube With TaperGuard Cuff, Reusable Inner Cannula |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | COVIDIEN 6135 GUNBARREL AVE Boulder, CO 80301 |
| Contact | Danielle Mueller |
| Correspondent | Danielle Mueller COVIDIEN 6135 GUNBARREL AVE Boulder, CO 80301 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521205526 | K150844 | 000 |
| 20884521205427 | K150844 | 000 |
| 20884521205434 | K150844 | 000 |
| 20884521205441 | K150844 | 000 |
| 20884521205465 | K150844 | 000 |
| 20884521205472 | K150844 | 000 |
| 20884521205489 | K150844 | 000 |
| 20884521205496 | K150844 | 000 |
| 20884521205502 | K150844 | 000 |
| 20884521205519 | K150844 | 000 |
| 20884521205533 | K150844 | 000 |
| 20884521205540 | K150844 | 000 |
| 20884521205458 | K150844 | 000 |
| 20884521205021 | K150844 | 000 |