The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex Blue Line Sacett Suction Above The Cuff Tracheal Tube, Size 6.0 And 6.5, 7.0 And 7.5, 8.0 And 8.5, 9.0.
| Device ID | K081086 |
| 510k Number | K081086 |
| Device Name: | PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0 |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | SMITHS MEDICAL ASD, INC. MILITARY ROAD Hythe, Kent, GB Ct216jl |
| Contact | John Tullett |
| Correspondent | John Tullett SMITHS MEDICAL ASD, INC. MILITARY ROAD Hythe, Kent, GB Ct216jl |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315059562 | K081086 | 000 |
| 55019315059559 | K081086 | 000 |
| 35019315059548 | K081086 | 000 |
| 35019315059531 | K081086 | 000 |
| 35019315059524 | K081086 | 000 |
| 55019315059511 | K081086 | 000 |
| 35019315059500 | K081086 | 000 |