The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Shiley Tracheosoft Xlt Extended Length Tracheostomy Tube And Inner Cannula.
| Device ID | K051416 |
| 510k Number | K051416 |
| Device Name: | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | MALLINCKRODT MEDICAL 4280 HACIENDA DRIVE Pleasanton, CA 94588 |
| Contact | Patrick Garvey |
| Correspondent | Patrick Garvey MALLINCKRODT MEDICAL 4280 HACIENDA DRIVE Pleasanton, CA 94588 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-01 |
| Decision Date | 2005-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50884522006734 | K051416 | 000 |
| 20884522043677 | K051416 | 000 |
| 20884522028186 | K051416 | 000 |
| 30884522027933 | K051416 | 000 |
| 30884522027919 | K051416 | 000 |
| 30884522027902 | K051416 | 000 |
| 20884522025116 | K051416 | 000 |
| 20884522025109 | K051416 | 000 |
| 20884522025093 | K051416 | 000 |
| 20884522043684 | K051416 | 000 |
| 20884522043691 | K051416 | 000 |
| 50884522006727 | K051416 | 000 |
| 40884522006713 | K051416 | 000 |
| 60884522006748 | K051416 | 000 |
| 30884522028190 | K051416 | 000 |
| 30884522028176 | K051416 | 000 |
| 30884522028169 | K051416 | 000 |
| 30884522027926 | K051416 | 000 |
| 20884522043707 | K051416 | 000 |
| 20884522025086 | K051416 | 000 |