The following data is part of a premarket notification filed by Transtracheal Systems with the FDA for Modified Scoop Transtracheal Catheters.
| Device ID | K902281 |
| 510k Number | K902281 |
| Device Name: | MODIFIED SCOOP TRANSTRACHEAL CATHETERS |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| Applicant | TRANSTRACHEAL SYSTEMS 8755 EAST ORCHARD ROAD, STE.607 Englewood, CO 80111 |
| Contact | W Peterson |
| Correspondent | W Peterson TRANSTRACHEAL SYSTEMS 8755 EAST ORCHARD ROAD, STE.607 Englewood, CO 80111 |
| Product Code | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-22 |
| Decision Date | 1990-08-10 |