The following data is part of a premarket notification filed by Smiths Medical International with the FDA for Portex Percutaneous Tracheostomy Kit.
| Device ID | K060945 |
| 510k Number | K060945 |
| Device Name: | PORTEX PERCUTANEOUS TRACHEOSTOMY KIT |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | SMITHS MEDICAL INTERNATIONAL 1 ST. CRISPIN WAY HASLINGDEN Rossendale, Lancashire, GB Bb4 4pw |
| Contact | Stewart Lee |
| Correspondent | Stewart Lee SMITHS MEDICAL INTERNATIONAL 1 ST. CRISPIN WAY HASLINGDEN Rossendale, Lancashire, GB Bb4 4pw |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315106891 | K060945 | 000 |
| 15019315028793 | K060945 | 000 |
| 15019315028809 | K060945 | 000 |
| 15019315042676 | K060945 | 000 |
| 15019315042683 | K060945 | 000 |
| 15019315042690 | K060945 | 000 |
| 35019315065969 | K060945 | 000 |
| 35019315066171 | K060945 | 000 |
| 35019315069349 | K060945 | 000 |
| 35019315075197 | K060945 | 000 |
| 35019315075203 | K060945 | 000 |
| 35019315075210 | K060945 | 000 |
| 55019315106604 | K060945 | 000 |
| 35019315106617 | K060945 | 000 |
| 35019315106662 | K060945 | 000 |
| 55019315106871 | K060945 | 000 |
| 55019315106888 | K060945 | 000 |
| 15019315028786 | K060945 | 000 |