The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Bluxl Extra Length Tracheostomy Tube, Bluxl Suctionaid Extra Length Tracheostomy Tube, Bluxl Extra Length Tracheostomy Inner Cannula.
| Device ID | K210833 |
| 510k Number | K210833 |
| Device Name: | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | Nancy Deangelo |
| Correspondent | Nancy Deangelo Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-19 |
| Decision Date | 2021-11-26 |