The following data is part of a premarket notification filed by Transtracheal Systems with the FDA for Transtracheal System-scoop-insertion Tray-catheter.
| Device ID | K854252 |
| 510k Number | K854252 |
| Device Name: | TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | TRANSTRACHEAL SYSTEMS 1721 EAST 19TH. AVE. SUITE 404 Denver, CO 80218 |
| Contact | Peter L Durante |
| Correspondent | Peter L Durante TRANSTRACHEAL SYSTEMS 1721 EAST 19TH. AVE. SUITE 404 Denver, CO 80218 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-22 |
| Decision Date | 1986-02-03 |