The following data is part of a premarket notification filed by Portex Ltd. with the FDA for Portex Blue Line Ultra Tracheostomy Tube (cuffed) With Reusable Inner Cannula.
| Device ID | K030381 |
| 510k Number | K030381 |
| Device Name: | PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PORTEX LTD. MILITARY ROAD HYTHE, KENT England Ct21 6db, GB |
| Contact | Steve Ogilvie |
| Correspondent | Steve Ogilvie PORTEX LTD. MILITARY ROAD HYTHE, KENT England Ct21 6db, GB |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-05 |
| Decision Date | 2003-08-27 |
| Summary: | summary |