The following data is part of a premarket notification filed by Portex Ltd. with the FDA for P0rtex Reinforced Tracheal Tube (cuffed And Uncuffed).
| Device ID | K032112 |
| 510k Number | K032112 |
| Device Name: | P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) |
| Classification | Tube, Tracheal (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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-09 |
| Decision Date | 2004-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 55019315051348 | K032112 | 000 |
| 35019315050750 | K032112 | 000 |
| 55019315050761 | K032112 | 000 |
| 35019315050774 | K032112 | 000 |
| 35019315050781 | K032112 | 000 |
| 35019315050798 | K032112 | 000 |
| 55019315050808 | K032112 | 000 |
| 35019315050811 | K032112 | 000 |
| 55019315050822 | K032112 | 000 |
| 35019315050835 | K032112 | 000 |
| 35019315051306 | K032112 | 000 |
| 35019315051313 | K032112 | 000 |
| 55019315051324 | K032112 | 000 |
| 55019315051331 | K032112 | 000 |
| 35019315050743 | K032112 | 000 |