The following data is part of a premarket notification filed by Portex Ltd. with the FDA for Percutaneous Dilation Tracheostomy Kit With Single Stage Dilator And Soft Introducers For Sizes 7, 8 And 9mm Tubes Only.
| Device ID | K040014 |
| 510k Number | K040014 |
| Device Name: | PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | PORTEX LTD. MILITARY ROAD Hythe, Kent, GB Ct21 6db |
| Contact | Barry Smith |
| Correspondent | Barry Smith PORTEX LTD. MILITARY ROAD Hythe, Kent, GB Ct21 6db |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-02-13 |
| Summary: | summary |