The following data is part of a premarket notification filed by Smiths Medical with the FDA for Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators Or Single Stage Dilator, Blue Line Ultra.
| Device ID | K041348 |
| 510k Number | K041348 |
| Device Name: | PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | SMITHS MEDICAL MILITARY ROAD Hythe, Kent, GB Ct 21 5bn |
| Contact | Barry Smith |
| Correspondent | Barry Smith SMITHS MEDICAL MILITARY ROAD Hythe, Kent, GB Ct 21 5bn |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-20 |
| Decision Date | 2004-07-13 |
| Summary: | summary |