The following data is part of a premarket notification filed by Covidien with the FDA for Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes With Taperguard Cuff.
| Device ID | K142298 |
| 510k Number | K142298 |
| Device Name: | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes With TaperGuard Cuff |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | Covidien 6135 Gunbarrel Avenue Boulder, CO 80301 |
| Contact | Kelsey Lee |
| Correspondent | Danielle Mueller Covidien 6135 Gunbarrel Avenue 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 | 2015-02-13 |
| Summary: | summary |