The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Uncuffed Reinforced Tracheal Tube.
| Device ID | K841872 |
| 510k Number | K841872 |
| Device Name: | UNCUFFED REINFORCED TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-07 |
| Decision Date | 1984-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50884522029207 | K841872 | 000 |
| 20884522029152 | K841872 | 000 |
| 20884522029169 | K841872 | 000 |
| 10884522029179 | K841872 | 000 |
| 20884522029183 | K841872 | 000 |
| 20884522029190 | K841872 | 000 |
| 20884522029206 | K841872 | 000 |
| 40884522029149 | K841872 | 000 |
| 40884522029156 | K841872 | 000 |
| 50884522029160 | K841872 | 000 |
| 50884522029177 | K841872 | 000 |
| 40884522029187 | K841872 | 000 |
| 40884522029194 | K841872 | 000 |
| 10884522029148 | K841872 | 000 |