The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Blue Line Ultra Paediatric Tracheosomy Tube.
| Device ID | K170720 |
| 510k Number | K170720 |
| Device Name: | Portex Blue Line Ultra Paediatric Tracheosomy Tube |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 |
| Contact | James Taufen |
| Correspondent | James Taufen 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 | 2017-03-09 |
| Decision Date | 2017-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55019517046227 | K170720 | 000 |
| 35019517046216 | K170720 | 000 |
| 35019517046209 | K170720 | 000 |
| 35019517046193 | K170720 | 000 |
| 35019517046186 | K170720 | 000 |