The following data is part of a premarket notification filed by Covidien with the FDA for Shiley Neonatal/pediatric Tracheostomy Tube.
| Device ID | K182861 |
| 510k Number | K182861 |
| Device Name: | Shiley Neonatal/Pediatric Tracheostomy Tube |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | Covidien 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Yaara Basevitch |
| Correspondent | Yaara Basevitch 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 | 2018-10-11 |
| Decision Date | 2019-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521177199 | K182861 | 000 |
| 20884521103556 | K182861 | 000 |
| 20884521103563 | K182861 | 000 |
| 20884521103570 | K182861 | 000 |
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| 20884521103471 | K182861 | 000 |
| 20884521103488 | K182861 | 000 |
| 20884521103495 | K182861 | 000 |
| 10884521779693 | K182861 | 000 |