The following data is part of a premarket notification filed by Transtracheal Systems with the FDA for Scoop 1.
| Device ID | K981080 |
| 510k Number | K981080 |
| Device Name: | SCOOP 1 |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | TRANSTRACHEAL SYSTEMS 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lesis Ward |
| Correspondent | Lesis Ward TRANSTRACHEAL SYSTEMS 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-24 |
| Decision Date | 1998-06-17 |