The following data is part of a premarket notification filed by Portex Ltd. with the FDA for Blue Line Ultra Suctionaid Tracheostomy Tube.
| Device ID | K030570 |
| 510k Number | K030570 |
| Device Name: | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | PORTEX LTD. MILITARY ROAD Hyth, Kent, GB Ct21 6db |
| Contact | Steve Ogilvie |
| Correspondent | Steve Ogilvie PORTEX LTD. MILITARY ROAD Hyth, Kent, GB Ct21 6db |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-24 |
| Decision Date | 2003-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315104880 | K030570 | 000 |
| 55019315047396 | K030570 | 000 |
| 55019315047372 | K030570 | 000 |
| 55019315047358 | K030570 | 000 |
| 55019315047334 | K030570 | 000 |
| 35019315038833 | K030570 | 000 |
| 35019315038826 | K030570 | 000 |
| 35019315038819 | K030570 | 000 |
| 35019315038802 | K030570 | 000 |
| 35019315038796 | K030570 | 000 |
| 55019315038783 | K030570 | 000 |
| 55019315047419 | K030570 | 000 |
| 35019315047439 | K030570 | 000 |
| 35019315047453 | K030570 | 000 |
| 35019315104873 | K030570 | 000 |
| 35019315104866 | K030570 | 000 |
| 35019315104859 | K030570 | 000 |
| 55019315104846 | K030570 | 000 |
| 35019315104835 | K030570 | 000 |
| 35019315059418 | K030570 | 000 |
| 35019315047538 | K030570 | 000 |
| 35019315047514 | K030570 | 000 |
| 35019315047491 | K030570 | 000 |
| 55019315047471 | K030570 | 000 |
| 55019315038776 | K030570 | 000 |