The following data is part of a premarket notification filed by Covidien with the FDA for Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube With Taperguard Cuff, Disposable Inner Cannula.
| Device ID | K142296 |
| 510k Number | K142296 |
| Device Name: | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube With TaperGuard Cuff, Disposable 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 | 2014-08-18 |
| Decision Date | 2015-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521176355 | K142296 | 000 |
| 10884521175693 | K142296 | 000 |
| 20884521172507 | K142296 | 000 |
| 20884521172514 | K142296 | 000 |
| 20884521172491 | K142296 | 000 |
| 20884521172484 | K142296 | 000 |
| 20884521172477 | K142296 | 000 |
| 20884521172460 | K142296 | 000 |
| 20884521172453 | K142296 | 000 |
| 20884521172378 | K142296 | 000 |
| 10884521176546 | K142296 | 000 |
| 20884521176567 | K142296 | 000 |
| 10884521176577 | K142296 | 000 |
| 20884521176581 | K142296 | 000 |
| 10884521176591 | K142296 | 000 |
| 20884521176604 | K142296 | 000 |
| 10884521175709 | K142296 | 000 |
| 10884521175716 | K142296 | 000 |
| 10884521175723 | K142296 | 000 |
| 10884521176348 | K142296 | 000 |
| 10884521176331 | K142296 | 000 |
| 10884521176324 | K142296 | 000 |
| 10884521176317 | K142296 | 000 |
| 10884521176300 | K142296 | 000 |
| 10884521176294 | K142296 | 000 |
| 10884521176287 | K142296 | 000 |
| 10884521176270 | K142296 | 000 |
| 10884521176263 | K142296 | 000 |
| 10884521176256 | K142296 | 000 |
| 10884521176249 | K142296 | 000 |
| 10884521176232 | K142296 | 000 |
| 10884521175754 | K142296 | 000 |
| 10884521175747 | K142296 | 000 |
| 10884521175730 | K142296 | 000 |
| 10884521511965 | K142296 | 000 |