The following data is part of a premarket notification filed by Covidien with the FDA for Shiley Adult Flexible Evac Tracheostomy Tube With Taperguard Cuff.
| Device ID | K193077 |
| 510k Number | K193077 |
| Device Name: | Shiley Adult Flexible Evac Tracheostomy Tube With TaperGuard Cuff |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | Covidien 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Stacy Barton |
| Correspondent | Stacy Barton 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 | 2019-11-05 |
| Decision Date | 2020-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521726212 | K193077 | 000 |
| 20884521726250 | K193077 | 000 |
| 20884521726229 | K193077 | 000 |
| 20884521726205 | K193077 | 000 |
| 20884521726441 | K193077 | 000 |
| 20884521726427 | K193077 | 000 |
| 20884521726403 | K193077 | 000 |
| 20884521726397 | K193077 | 000 |
| 20884521726311 | K193077 | 000 |
| 20884521726267 | K193077 | 000 |
| 20884521726274 | K193077 | 000 |
| 20884521726281 | K193077 | 000 |
| 20884521726199 | K193077 | 000 |
| 20884521726243 | K193077 | 000 |
| 20884521726434 | K193077 | 000 |
| 20884521726304 | K193077 | 000 |
| 20884521726236 | K193077 | 000 |
| 20884521726458 | K193077 | 000 |
| 20884521726410 | K193077 | 000 |
| 20884521726328 | K193077 | 000 |
| 20884521726298 | K193077 | 000 |