The following data is part of a premarket notification filed by Covidien with the FDA for Mallinckrodt Oral/nasal Tracheal Tube Cuffless, Non-dehp, Murphy Eye.
| Device ID | K151381 |
| 510k Number | K151381 |
| Device Name: | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Covidien 6135 Gunbarrel Ave Boulder, CO 80301 |
| Contact | Danielle Mueller |
| Correspondent | Danielle Mueller Covidien 6135 Gunbarrel Ave Boulder, CO 80301 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-22 |
| Decision Date | 2015-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884521797257 | K151381 | 000 |
| 30884521620234 | K151381 | 000 |
| 30884521619986 | K151381 | 000 |
| 30884521619979 | K151381 | 000 |
| 30884521619962 | K151381 | 000 |
| 30884521619955 | K151381 | 000 |
| 30884521619931 | K151381 | 000 |
| 30884521619917 | K151381 | 000 |
| 30884521797288 | K151381 | 000 |
| 30884521620241 | K151381 | 000 |
| 30884521212842 | K151381 | 000 |
| 10884521620254 | K151381 | 000 |
| 20884521797342 | K151381 | 000 |
| 20884521797335 | K151381 | 000 |
| 30884521797325 | K151381 | 000 |
| 20884521797311 | K151381 | 000 |
| 30884521797295 | K151381 | 000 |
| 20884521797274 | K151381 | 000 |
| 30884521797264 | K151381 | 000 |
| 30884521797240 | K151381 | 000 |
| 20884521619927 | K151381 | 000 |